Sterilizing method and apparatus

ABSTRACT

A sterilization container for retaining surgical instruments in a sterilizer comprising a plurality of walls defining an interior volume sized to receive at least one instrument tray, least one of the walls defining a venting pass through area, and a filter occluding the venting passage area, wherein a ratio of the venting pass through area to the interior volume is at least 1 square inch:125 cubic inches.

BACKGROUND OF THE INVENTION Field of the Invention

Exemplary embodiments of the present disclosure relate to a method andapparatus for sterilization and more particularly to a method andapparatus for sterilization of instruments, wherein a ratio of ventingpass through area to volume of the sterilization container is at least agiven value, and wherein the given value in select configurations canprovide a drying time of less than 30 minutes and in selectconfigurations less than 15 minutes.

Description of Related Art

Sterilization is a term referring to any process that eliminates(removes) or kills microbial life, including transmissible agents (suchas fungi, bacteria, viruses, or spore forms) present on a surface, orcontained in a fluid, or in medication, or in a compound such asbiological culture media. Sterilization can be achieved by applyingheat, chemicals, irradiation, high pressure, and filtration orcombinations thereof.

In general, surgical instruments and medications that enter an alreadyaseptic part of the body (such as the bloodstream, or penetrating theskin) must be sterilized to a high sterility assurance level. Examplesof such instruments include scalpels, hypodermic needles and implantablemedical devices (IMD), such as artificial pacemakers.

A widely used method for heat sterilization is the autoclave, sometimesreferred to as a sterilizer. Autoclaves commonly use steam heated to121-134° C. To achieve a degree of sterility, a holding time of at least15 minutes at 121° C. at 100 kPA, or 3 minutes at 134° C. at 100 kPa isrequired. Additional sterilizing time is usually required for liquidsand instruments packed in layers of cloth, as they may take longer toreach the required temperature.

One method of sterilization involves passing steam through a container.For effective sterilization, steam needs to penetrate the container loaduniformly. Accordingly, the container must not be overcrowded, and thelids of bottles and containers must be left ajar. During the initialheating of the container, residual air must be removed. Indicatorsshould be placed in the most difficult places for the steam to reach toensure that steam actually penetrates there.

A filter is typically placed over the vent to keep particles orextraneous materials from entering the container before, during or afterthe sterilizing process. Once the sterilizing process is completed, thefilter needs to be removed and inspected by medical professionals toverify the integrity of the sterilizing process was maintained. If it isdiscovered during inspection that the filter did not remain intact, thesterilizing process has to be repeated with a new filter. Further, ifmoisture is present in the container, the load would be rejected by theuser and sent for reprocessing. Thus, a sufficient drying time, whereinthere is no visible moisture on the sterilized medical instruments, isneeded before the sterilization processing is complete.

The amount of drying time needed to achieve a dry load can besignificant. Dry time can add several minutes to the total processingtime in order to achieve a load where the instruments are dry. Further,heavier loads, for example, those with a large metal mass, can causemoisture to be maintained inside the container after the sterilizationcycle is complete. Thus, weight limits may be required to avoid wet,unsterilized loads after processing. In existing devices, asterilization cycle may run for 4 minutes at 270° F., followed by atleast a 30 minute dry cycle. These containers have relatively small ventarea to volume ratios, wherein an area of the vent is small compared tothe internal volume of the container. For example, in the S.C.O.R.E.S.container labelled by PMBS, LLC of Stockton N.J., the ratio of the areaof the vent to volume is approximately 0.004-0.006 in² per in³. Thesevent area to volume ratios limit circulation through the container,contribute to the longer dry times required for achieving a dry load,and significantly limit the weight of the load that can be placed intothe container.

What is needed, then, is a sterilization container for retainingsurgical instruments in a sterilizer that has improved circulation andevaporation and shorter drying times.

BRIEF SUMMARY OF THE INVENTION

In view of the foregoing, a sterilization container for retaining asurgical instrument in a sterilizer is provided.

A first exemplary embodiment provides a sterilization container forretaining surgical instruments in a sterilizer. The sterilizationcontainer comprises an enclosing wall and a door defining an interiorvolume sized to receive at least one instrument tray, at least one ofthe enclosing wall and the door defining a venting pass through area,and a filter occluding the venting pass through area, wherein a ratio ofthe venting pass through area to the interior volume is at least 0.008inch² per inch³, and in select configurations at least 0.016 inch² perinch³, and in further configurations greater than 0.02 inch² per inch³.In further configurations, the ratio of the venting pass through area tothe interior volume is between least 0.008 inch² per inch³ and 0.2 inch²per inch³ and in select configurations between 0.016 inch² per inch³,and 0.2 inch² per inch³.

The enclosing wall of the sterilization container can be any of avariety of configurations, such as but not limited to defining polygonalcontainers, containers with curvilinear walls or combinations thereof.For purposes of description, the sterilization container has been setfor in terms of walls forming the enclosing wall. Thus, in a furtherconfiguration, the sterilization container comprises an enclosing wallhaving a plurality of walls and a door defining an interior volume sizedto receive at least one instrument tray, at least one of the walls andthe door defining a venting pass through area, and a filter occludingthe venting passage area, wherein a ratio of the venting pass througharea to the interior volume is at least 0.008 inch² per inch³, and inselect configurations at least 0.16 inch² per inch³, and in furtherconfigurations greater than 0.2 inch² per inch³.

Further, the configurations are set forth in terms of a sterilizationcontainer, which encompasses a sterilization cabinet.

Another exemplary embodiment provides a method of drying contents in asterilization container, the method comprising sterilizing contents in asterilization container having an enclosing wall, such as a plurality ofwalls, and a door defining an interior volume sized to receive at leastone instrument tray retaining the contents, venting the sterilizationcontainer through a venting pass through area having a filter occludingthe venting passage area, wherein a ratio of the venting pass througharea to the interior volume is at least 0.008 inch² per inch³, andobtaining a drying of the contents in the sterilizing cabinet in lessthan 30 minutes and in select configurations less than 15 minutes.

A further exemplary embodiment provides a sterilization container forretaining surgical instruments in a sterilizer, the sterilizationcontainer comprising an enclosing wall, such as a plurality of walls anda door defining an interior volume sized to receive at least oneinstrument tray, at least one of the enclosing wall and the doordefining a venting pass through area, and a filter occluding the ventingpassage area, the sterilization container having a ratio of the ventingpass through area to the interior volume sufficient to provide a dryingtime of less than 30 minutes and in select configurations less than 15minutes.

Yet another exemplary embodiment provides a sterilization container forsterilizing instruments in a sterilizer using a sterilizing agent, thesterilization container comprising an opening defined by a perimeter ofan enclosing wall, the enclosing wall defining an interior volume sizedto receive a plurality of instrument trays, a door moveable between anopen position and a closed position, wherein the interior volume isaccessible through the opening when the door is in the open position,and a filter cartridge having a gasket surrounding a first filtercomprising a porous material wherein the filter cartridge is removablysecured to the door when the door is in the open position, and whereinthe gasket is positioned between the door and the enclosing wall to forma sealed interface between at least one of the door and the enclosingwall when the door is in the closed position.

Another exemplary embodiment provides a sterilization container forsterilizing instruments in a sterilizer using a sterilizing agent, thesterilization container comprising an enclosing wall and a door defininga total surface area and an interior volume sized to receive a pluralityof instrument trays, at least one of the enclosing wall and the doordefining a venting pass through area, wherein the door is moveablebetween an open position and a closed position, and wherein the interiorvolume is accessible when the door is in the open position, and a filtercartridge having a gasket surrounding a first filter, wherein the filtercartridge provides sufficient structural integrity to form a sealinginterface with at least one of a confronting surface of the enclosingwall and the door, wherein the first filter occludes the venting passthrough area, and wherein the venting pass through area is at least 5.7%of the total surface area.

A further exemplary embodiment provides a method of sterilizing items ina sterilization container, the method comprising placing items to besterilized into an interior volume of a sterilization container havingat least one door, the interior volume defined by an enclosing wall, theenclosing wall and door defining a total surface area of thesterilization container, and securing a filter cartridge having a gasketsurrounding a first filter to the door, wherein the filter cartridge issized to position the gasket between confronting surfaces of the doorand the enclosing wall to engage at least one of the door and theenclosing wall when the door is in a closed position.

The method of sterilizing items in a sterilization container may furthercomprise the steps of securing the door in the closed position tocompress the gasket and form a sealed interface between at least one ofthe door and the enclosing wall, and sterilizing items in thesterilization container in a sterilizer wherein the sterilizationcontainer is vented through a venting pass through area having the firstfilter occluding the venting pass through area, wherein the venting passthrough area is at least 5.7% of the total surface area.

Further, the method of sterilizing items in a sterilization containermay further comprise the step of drying the items in the sterilizationcontainer in less than 30 minutes, moving the door into an openposition, wherein the filter cartridge remains secured to the door,releasing the filter cartridge from the door, and disposing of thefilter cartridge.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

FIG. 1a is a front view of a configuration of a sterilization containersuch as a sterilization cabinet suitable for use in practicing exemplaryembodiments of this disclosure.

FIG. 1b is a top view of a configuration of a sterilization containersuch as a sterilization cabinet suitable for use in practicing exemplaryembodiments of this disclosure.

FIG. 1c is a side view of a configuration of a sterilization containersuch as a sterilization cabinet suitable for use in practicing exemplaryembodiments of this disclosure.

FIG. 2a is a perspective view of an alternative configuration of asterilization container such as a sterilization cabinet suitable for usein practicing exemplary embodiments of this disclosure.

FIG. 2b is a top view of an alternative configuration of a sterilizationcontainer such as a sterilization cabinet suitable for use in practicingexemplary embodiments of this disclosure.

FIG. 3a is a top view of a vent of a sterilization container such as asterilization cabinet suitable for use in practicing exemplaryembodiments of this disclosure.

FIG. 3b is a perspective view of a filter arrangement of a sterilizationcontainer such as a sterilization cabinet for use in practicingexemplary embodiments of this disclosure.

FIG. 4a is a perspective view of the movement of a filter arrangement ofa sterilization container such as a sterilization cabinet for use inpracticing exemplary embodiments of this disclosure.

FIG. 4b is a perspective view of the movement of an alternative filterarrangement of a sterilization container such as a sterilization cabinetfor use in practicing exemplary embodiments of this disclosure.

FIG. 5a is a perspective view of an alternative configuration of asterilization container such as a sterilization cabinet suitable for usein practicing exemplary embodiments of this disclosure.

FIG. 5b is a perspective view of bottom section of a filter arrangementof a sterilization container such as a sterilization cabinet suitablefor use in practicing exemplary embodiments of this disclosure.

FIG. 5c is a perspective view of a middle section of a filterarrangement of a sterilization container such as a sterilization cabinetsuitable for use in practicing exemplary embodiments of this disclosure.

FIG. 5d is a perspective view of top section of a filter arrangement ofa sterilization container such as a sterilization cabinet suitable foruse in practicing exemplary embodiments of this disclosure.

FIG. 6a is a perspective view of an alternative sterilization containersuch as a sterilization cabinet suitable for use in practicing exemplaryembodiments of this disclosure.

FIG. 6b is a front view of an alternative filter arrangement of asterilization container such as a sterilization cabinet suitable for usein practicing exemplary embodiments of this disclosure.

FIG. 6c is a front view of the top portion of an alternative filterarrangement of a sterilization container such as a sterilization cabinetsuitable for use in practicing exemplary embodiments of this disclosure.

FIG. 7a is a perspective view of the separated elements of analternative filter arrangement of a sterilization container such as asterilization cabinet suitable for use in practicing exemplaryembodiments of this disclosure.

FIG. 7b is a perspective view of the separated elements of anotherfilter arrangement of a sterilization container such as a sterilizationcabinet suitable for use in practicing exemplary embodiments of thisinvention.

FIG. 8a is a top view of a spacer suitable for use in practicingexemplary embodiments of this disclosure.

FIG. 8b is a side view of a spacer suitable for use in practicingexemplary embodiments of this disclosure.

FIG. 8c is another side view of a spacer suitable for use in practicingexemplary embodiments of this disclosure.

FIG. 9a is a top view of an alternative spacer suitable for use inpracticing exemplary embodiments of this disclosure.

FIG. 9b is a side view of an alternative spacer suitable for use inpracticing exemplary embodiments of this disclosure.

FIG. 9c is another side view of an alternative spacer suitable for usein practicing exemplary embodiments of this disclosure.

FIG. 10 is a perspective view of a sterilizing tray suitable for use inpracticing exemplary embodiments of this disclosure.

FIG. 11 is a perspective view of a sterilization container such as asterilization cabinet suitable for use in practicing exemplaryembodiments of this disclosure.

FIG. 12 is a perspective view of a pan assembly suitable for use inpracticing exemplary embodiments of this disclosure.

FIG. 13a is a perspective view of a filter suitable for use inpracticing exemplary embodiments of this disclosure.

FIG. 13b is a side view of a filter suitable for use in practicingexemplary embodiments of this disclosure.

FIG. 14a is a perspective view of an alternative filter suitable for usein practicing exemplary embodiments of this disclosure.

FIG. 14b is a side view of an alternative filter suitable for use inpracticing exemplary embodiments of this disclosure.

FIG. 15a is a perspective view of another filter suitable for use inpracticing exemplary embodiments of this disclosure.

FIG. 15b is a side view of another filter suitable for use in practicingexemplary embodiments of this disclosure.

FIG. 16 is a perspective view of a filter cartridge suitable for use inpracticing exemplary embodiments of this disclosure.

FIG. 17 is a perspective view of an alternative filter cartridgesuitable in practicing exemplary embodiments of this disclosure.

FIG. 18 is a perspective view of an alternative filter cartridgesuitable in practicing exemplary embodiments of this disclosure.

FIG. 19 is a perspective view of another filter cartridge suitable inpracticing exemplary embodiments of this disclosure.

FIG. 20 is a filter cartridge holder suitable in practicing exemplaryembodiments of this disclosure.

FIG. 21 is a magnified cross-sectional view of a sterilization containersuch as a sterilization cabinet and a filter door suitable for use inpracticing exemplary embodiments of this disclosure.

FIG. 22 is a perspective view of an exemplary a sterilization containersuch as a sterilization cabinet and filter door suitable for use inpracticing exemplary embodiments of the present disclosure.

FIG. 23 is a perspective view of an exemplary a sterilization containersuch as a sterilization cabinet and filter door suitable for use inpracticing exemplary embodiments of the present disclosure.

FIG. 24 is a bottom perspective view of an exemplary sterilizationcontainer such as a sterilization cabinet suitable for use in practicingexemplary embodiments of the present disclosure.

FIG. 25 is a perspective view of an alternative embodiment of asterilization container such as a sterilization cabinet suitable for usein practicing exemplary embodiments of this disclosure.

FIG. 26 is a perspective view of a separated alternative embodiment of asterilization container such as a sterilization cabinet suitable for usein practicing exemplary embodiments of this disclosure.

FIG. 27 is a perspective view of an alternative embodiment of asterilization container such as a sterilization cabinet suitable for usein practicing exemplary embodiments of this disclosure.

FIG. 28 is a perspective view of yet another alternative embodiment of asterilization container such as a sterilization cabinet suitable for usein practicing exemplary embodiments of this disclosure.

FIG. 29 is a side view of an embodiment of a sterilizing cabinetsuitable for use in practicing exemplary embodiments of this disclosure.

FIG. 30 is another embodiment of a sterilizing cabinet suitable for usein practicing exemplary embodiments of this disclosure.

FIG. 31 is an internal view of an exemplary sterilizing cabinet suitablefor use in practicing exemplary embodiments of this disclosure.

FIG. 32 is an internal view of an exemplary sterilizing cabinet suitablefor use in practicing exemplary embodiments of this disclosure.

DETAILED DESCRIPTION OF THE INVENTION

In the medical field, it is of the utmost importance that medicalinstruments are sterilized prior to any medical procedure. Thisdrastically helps prevent the spread of infectious materials. In themarketplace, there are a wide variety of devices that provide forsterilization of medical instruments through the use of a sterilizingagent, such as steam. Instrument trays can be wrapped in a cloth orpaper that acts as a filter, allowing the tray to be sterilized, thendelivered to the operating room. Alternatively, a rigid container cancontain the instrument tray. The device (e.g., a rigid container,sterilization container or cabinet) contains at least one vent forventing the steam used to sterilize the contents of the device. Adisposable filter usually covers these vents. The filters have two majorpurposes. First, the filters prevent extraneous materials from enteringthe sterilizing device during and after the sterilization cycle. Second,the filters allow sterilizing steam to enter and exit the sterilizingdevice (sterilization container). Thus, the sterilization container canretain the sterilized medical instruments within the container andprotected from the environment by the filters sealing the vents. Thefilter can be made of any type of porous paper or cellulose typematerial. In other embodiments, the filter is made of polymericsubstances, such as polypropylene or a combination such as plasticizedpaper as known in the art. The filter is required to be both porous anddense enough to allow the passage of a sterilizing agent, such as steam,through its membrane, but also resilient enough to not rip or tearduring a sterilizing cycle or during insertion/clamping into operableposition. Although the present description is set forth in terms of apaper-like filter, the filter can be a tortuous path or even a valvethat acts as a check valve permitting the venting of the sterilizationcontainer without permitting passage of extraneous materials into thesterilization container.

Referring to FIGS. 1a-3b , the sterilization container 100,alternatively referred to as the sterilization cabinet is shown. Forpurposes of the present description, the sterilization container is setforth as a sterilization cabinet. However, it is understood, thedisclosure is not limited to the sterilization cabinet and can be anysterilization container. And further, it should be noted thatembodiments of the present invention are not limited to the particularconfiguration of sterilizing cabinet 100.

The term sterilization cabinet 100 encompasses any device capable ofretaining the medical instruments subjected to the sterilizationprocedure, wherein the cabinet 100 can receive and retain at least onetray, with the tray retaining at least one medical instrument. Thesterilization cabinet 100 can retain the medical instruments in thesterilized condition after the sterilization process. The termsterilization container also includes sterilizing cabinets forsterilizing medical instruments, surgical devices and the like. The termsterilizer includes, but is not limited to, a housing or device definingan interior retaining the sterilization container and in which acontrolled environment is create to impart a desired sterilization.Sterilizers include autoclaves; hot air ovens; ethylene oxide; lowtemperature steam, steam, high pressure steam and formaldehyde;sporicidal chemicals; irradiation; chlorine dioxide (CD) gassterilization; hydrogen peroxide; vaporized hydrogen peroxide; hydrogenperoxide plasma; electron beam and gas plasma devices.

The sterilization cabinet 100 includes an enclosing wall which definesan interior volume, wherein the enclosing wall can include a pluralityof sidewalls, a top wall and a bottom wall. The walls can be planar orcurvilinear and can be oriented to define a rectilinear volume, cubicvolume or round or curved volume. For purposes of the presentdisclosure, the enclosing wall is set forth as the plurality ofsidewalls, the top wall and the bottom wall, along with a door. It isunderstood the enclosing wall can include or cooperate with a door to atleast partially define the interior volume. In one configuration thesterilization cabinet 100 includes the enclosing wall having theplurality of sidewalls, the top wall and the bottom wall, along with adoor or doors 102, vents 104, and in certain configurations filterholder 106, primary filter 108, secondary filter 110, sterilizationcabinet frame 112 and legs 114. Door or doors 102 are able to open andclose for access to the interior of sterilizing cabinet 100. Door ordoors 102 are physically connected to sterilization cabinet frame 112.Door or doors 102 can be attached through the use of a hinge or hingeswhich allows the doors to swing open. Alternatively, door or doors 102can be removable from sterilization cabinet 100 through the use ofclamps (not shown in FIG. 1). It should be appreciated that exemplaryembodiments of door or doors 102 include any mechanism that allows fordoor or doors 102 to move from an open position to a closed position toprovide access to the interior of sterilization cabinet 100. The doorcan effectively form a wall of the sterilization cabinet, as seen in theFigures.

Sterilization cabinet 100 in one embodiment provides for four vents 104.However, it should be appreciated that exemplary embodiments ofsterilizing cabinet 100 are not limited to four vents. The sterilizationcabinet 100 may include a fewer number or a greater number of vents 104.The vents 104 can define a venting pass through area 140 of thesterilizing cabinet 100. It should be appreciated that vents 104 canprovide numerous small openings for the passage of sterilizing steam orheat. The small openings in vents 104 can be holes or slits.Alternatively, vents 104 can be fenestrated. By “venting pass througharea” it is meant to refer to the total available area for the ingressand egress of a gas to or from the interior volume of the sterilizingcabinet 100. Exemplary embodiments of sterilization cabinet 100 caninclude one or more vents so long as the venting pass through area tovolume ratio is equal to or greater than 0.008 inch² per inch³, or 1inch²: 125 inch³, and in select configurations between 0.02-0.2 inch²per inch³, or between 1 inch²:50 inch³ and 1 inch²:5 inch³, and infurther configurations between 0.16-0.2 inch² per inch³, or 4 inch²:25inch³ and 1 inch²:5 inch³.

The term “dry time” or “drying time” means the time required to provideno visible moisture in the sterilization container or on the sterilizedmedical instrument (or tray or wrapping, if used), as set forth in thegoverning regulations. For example, as set forth in AAMI ST79Comprehensive guide to steam sterilization and sterility assurance inhealth care facilities (AAMI/CDV-2 ST79), visible moisture left in(interior) or on (exterior) a package or tray within the sterilizationcontainer after sterilization and the proper cooling (drying) periodshould be considered a wet pack. Further, if moisture is present on orin two or more packages the load should be considered a wet load. Themoisture may be in the form of visible dampness, droplets, or puddles ofwater on or within a pack (or instrument or tray). If wet packs areobserved in the processing area they should not be released. If wetpacks are observed in the user area (e.g., in the OR) they should not beused.

By “venting pass through area to volume ratio,” it is meant the ratio ofthe total venting pass through area 140 of a sterilizing cabinet 100 tothe interior volume of the sterilization cabinet 100 ratio. Thus, forexample, a sterilizing cabinet 100 as shown in FIGS. 1a and 1b , withfour vents 104, two vents 104 on the top of the sterilizing cabinet 100and two vents 104 on the bottom of the sterilizing cabinet 100, eachventing area having a venting area of approximately 11.4 inches (L₂)×13inches (W₂), will have a total venting area of approximately 592 squareinches. The volume of the sterilization cabinet 100, wherein the lengthis approximately 34 inches (L₁), the width is approximately 17 inches(W₁), and the height is approximately 17 inches (Hi), is approximately9826 inches 3. Thus, sterilization cabinet 100 as shown in FIGS. 1a-2bwould have a venting pass through area to volume ratio of approximately0.06 inch² per inch³. In other exemplary embodiments of thesterilization cabinet 100, the venting pass through area to volume ratiois between approximately 0.02-0.2 inch² per inch³, or 1 square inch:50cubic inches and 1 square inch:5 cubic inches, and in someconfigurations between 0.16-0.2 inch² per inch³, or 4 square inches:25cubic inches and 1 square inch:5 cubic inches. The high venting passthrough area to volume ratio increases circulation and evaporation andreduces the drying time required after the sterilization cycle. Itshould be appreciated that exemplary embodiments of the sterilizingcabinet can be other dimensions, shapes and sizes that provide similarvent to volume ratios. For example, the upper limit of the venting passthrough area to volume ratio is 6 inch² to 1 inch³. However, frommanufacturing considerations and structural requirements, the upperrange of the venting pass through area to volume ratio is typicallybetween 2.5 inch² and 6 inch² to 1 inch³.

The sterilization cabinet 100 can retain multiple trays holding medicalinstruments and, because of the high venting pass through area to volumeratio, has a drying time of less than 30 minutes, and more specifically,between 10-15 minutes, and even more specifically 10 minutes. In oneconfiguration, the sterilizing cabinet 100 can hold up to 15 trays andeach tray holds up to 25 lbs of material to be sterilized. In aconfiguration of the invention, the dry time of less than 30 minutesincludes multiple trays loaded into the sterilization cabinet 100, thetrays holding a total of 140 lbs or less of material to be sterilized,and in select configurations less than 15 minutes dry time.

Primary filter 108 in conjunction with filter holder 106 covers vent104. Primary filter 108 with filter holder 106 forms a seal with theadjacent portions of sterilizing cabinet 100 such that during theoperation of a sterilizing cycle, any sterilizing steam that passesthrough the vent 104 must then pass through primary filter 108. Primaryfilter 108 can be made of a very thin paper. Exemplary embodimentsprovide that primary filter 108 can be made of any porous material that(1) allows for the passage of sterilizing steam from sterilizing cabinet100 and (2) prevents extraneous materials from passing through primaryfilter 108 and entering vent 104. Primary filter 108 is removable fromsterilizing cabinet 100 and is typically replaced with a new filterfollowing each sterilizing cycle.

Secondary filter 110 resides on top of primary filter 108 in filterholder 106. Secondary filter 110 covers primary filter 108 and forms aseal with primary filter 108 through filter holder 106 such that anysterilizing steam that passes through the vent 104 must then passthrough primary filter 108 and secondary filter 110. Secondary filter110 can be made of a very thin paper. Secondary filter 110 can be madeof any porous material that (1) allows for the passage of sterilizingsteam from sterilizing cabinet 100 and primary filter 108 and (2)prevents extraneous materials from passing through secondary filter 108.

Exemplary embodiments of this disclosure provide for secondary filter110 to form a sealed periphery with primary filter 108. In anotherexemplary embodiment the sealed interface between the primary filter 108and the adjacent portion of either the sterilizing cabinet 100 isindependent of an interface between secondary filter 110 and primaryfilter 108. One exemplary arrangement provides for primary filter 108and secondary filter 110 to be coextensive. In another exemplaryembodiment primary filter 108 and secondary filter 110 have differentfilter properties. For instance, primary filter 108 and secondary filter110 may filter different elements of the sterilizing agent which exitssterilizing cabinet 100 during a sterilization cycle. In an alternativeexemplary embodiment primary filter 108 and secondary filter 110 havesimilar filter properties. Another exemplary embodiment provides thatprimary filter 108 and secondary filter 110 are different colors.

In yet another exemplary embodiment, primary filter 108 may be the onlyfilter that covers vent 104. Here, primary filter 108 is removeably heldor maintained in place over vent 104 by filter holder 106. In thisembodiment, there is no secondary filter. Primary filter 108 forms aseal with the adjacent portions of sterilizing cabinet 100 such thatduring the operation of a sterilizing cycle, any sterilizing steam thatpasses through the vent 104 must then pass through primary filter 108.Again, in this embodiment, primary filter 108 can be made of any porousmaterial that (1) allows for the passage of sterilizing steam fromsterilizing cabinet 100 and (2) prevents extraneous materials frompassing through primary filter 108 and entering vent 104. Primary filter108 is removable from sterilizing cabinet 100 and is typically replacedwith a new filter following each sterilizing cycle.

Legs 114 reside on the bottom of sterilizing cabinet 100 and providespacing between the surface which sterilizing cabinet 100 rests and thebottom primary filter 108, secondary filter 110 and filter holder 106.

FIG. 1b provides a top view of sterilizing cabinet 100 showing vent 104covered by filter holder 106, primary filter 108, secondary filter 110,sterilizing cabinet frame 112 and hinge 116 of filter holder 106. Hinge116 with filter holder 106 allows a portion of filter holder 106 toswing open about hinge 116 such that primary filter 108 and secondaryfilter 110 can be removed independent of one another. In other words,filter holder 106 allows for secondary filter 110 to be released andremoved from filter holder 106 while simultaneously maintaining primaryfilter's 108 seal with sterilizing cabinet 100 over vent 104.

FIG. 1c shows a side view of sterilizing cabinet 100 includingsterilizing cabinet frame 112, vent 104, primary filter 108, secondaryfilter 110, filter holder 106 and hinge 116.

In exemplary embodiments sterilizing cabinet 100 may include a steamexposure indicator on either the primary filter 108 or the secondaryfilter 110 which designates when steam from sterilizing cabinet 100 haspassed through one of the filters. An example of one such steam exposureindicator is a tape that changes colors when exposed to steam.

FIG. 2a provides a perspective view of sterilizing cabinet 100 with twovents 104 on the top and two vents 104 on the bottom of sterilizingcabinet 100. FIG. 2a also includes primary filters 108 occluding vents104 and secondary filters 110 overlaying primary filters 108 withprimary filters 108 and secondary filters 110 each in filter holders106.

FIG. 2b provides a top view of sterilizing cabinet 100 with analternative exemplary embodiment of filter holder 106. Shown in FIG. 2bare two vents 104 occluded by primary filters 108 which are also coveredby secondary filters 110. In this exemplary embodiment filter holders106 do not have a swinging hinge which allows for the individualattachment and release of primary filters 108 and secondary filters 110.In this exemplary embodiment filter holders 106 allow for independentlyremoving primary filter 108 and secondary filter 110 through the use ofa sliding mechanism. Secondary filter 110 can be removed by sliding itout of filter holder 106 while maintaining primary filter's 108 sealwith sterilizing cabinet 100 around vent 104.

In another alternative exemplary embodiment, filter holder 106 againdoes not include a swinging hinge, but allows for the placement andremoval of only primary filter 108 by a sliding mechanism. In thisembodiment, there is no secondary filter 110. Only primary filter 108 inconjunction with filter holder 106 forms a sealed interface withsterilizing cabinet 100 occluding vents 104. Primary filter 108 can thenbe placed or removed by sliding into and out of filter holder 106.

In practice, an exemplary embodiment of a process of placing primaryfilter 108 and secondary filter 110 includes disposing primary filter108 to occlude a vent 104 of sterilizing cabinet 100 and forming a firstsealed interface with the sterilizing cabinet 100. The process continuesby forming a second sealed interface between secondary filter 110 (orconfirmatory filter) and at least a portion of one of sterilizingcabinet 100 and primary filter 108, a portion of the secondary filter110 overlying a portion of the primary filter 108. The process cancontinue by passing a sterilizing agent (typically steam) throughprimary filter 108 and secondary filter 110 and vent 104.

Also in practice, an exemplary embodiment of a process of placing only aprimary filter 108 includes disposing primary filter 108 with filterholder 106 to occlude vent 104 of sterilizing cabinet 100 creating asealed interface with the sterilizing cabinet 100. The process cancontinue by passing a sterilizing agent (typically steam) throughprimary filter 108 and vent 104. The process can then conclude withverifying the integrity of primary filter 108 by either inspectingprimary filter 108 while it covers vent 104 in filter holder 106 orafter it is removed from filter holder 106. The process may be repeatedif it is determined that the integrity of primary filter 108 wascompromised during the sterilizing process.

Exemplary embodiments of inspecting primary filter 108 and/or secondaryfilter 110 can include visual inspection by either medical or nonmedicalpersonnel, inspecting by an electronic device or machine, or inspectingthrough mechanical means. Exemplary embodiments of inspecting by anelectronic device or machine includes any type of device that is able toscan or image the primary filter 108 and/or secondary filter 110 suchthat the scanned or imaged picture of the primary filter 108 and/orsecondary filter 110 can be digitally viewed or examined forimperfections such as rips or cuts that would impact the integrity ofthe sterilization cycle. Exemplary embodiments of mechanical inspectionincludes any type of inspection means that physically test that theintegrity of the primary filter 108 and/or secondary filter 110 has beenmaintained.

It should be noted that exemplary embodiments of a sterilizing agentinclude any substance that provides for the destruction or eliminationof living organisms, which often include heat, steam, pressure, gas,plasma, irradiation, chemical compounds, and chemical vapor.

Exemplary embodiments of this process provide that the first sealedinterface is separate from the second sealed interface. Additionally,failure of the second sealed interface is independent of the firstsealed interface. For example, if the second sealed interface fails andleaks sterilizing steam during a sterilization cycle, the first sealedinterface should remain intact and should not be affected by the failureof the second sealed interface.

Referring to FIG. 3a , a top view of an exemplary vent 104 is shown.Provided is a fenestrated surface with numerous openings that allow forthe passage of a sterilizing agent, such as steam from sterilizingcabinet 100 during a sterilization cycle. It can be appreciated thatFIG. 3a merely represents one embodiment of vent 104 and that exemplaryembodiments of vent 104 include any arrangement of holes or openingsthat allow for the passage of a sterilizing agent.

FIG. 3b provides a top view of a filtering arrangement covering vent104. Shown in FIG. 3b is the top portion of secondary filter 110, filterholder 106 with hinges 116 and pin 118. Exemplary embodiments of thisarrangement provide for a silicon seal between filter holder 106 andprimary filter 108, between filter holder 106 and secondary filter 110and sterilizing cabinet 100. This seal serves two primary purposes.First, it forces all of the sterilizing agent that enters and exits thesterilizing cabinet 100 to pass through the filters. Second, it keepsextraneous materials from entering the sterilizing cabinet 100 throughvents 104, which are covered by primary filter 108 and secondary filter110.

It can be appreciated that exemplary embodiments of the sealed interfacebetween the primary filter 108 and the sterilizing cabinet 100 includesboth direct contact between primary filter 108 and sterilizing cabinet100 as well as indirect contact between primary filter 108 andsterilizing cabinet 100 through the use of a sealing agent, such ascaulk or an adhesive. Likewise, the sealed interface between thesecondary filter and the primary filter 108 or filter holder 106includes both direct contact between primary filter 108 or filter holder106 as well as indirect contact through the use of a sealing agent, suchas caulk or an adhesive.

Referring to FIG. 4a , provided is a side view of the different elementsand the type of movement allowed for filter holder 106 in exemplaryembodiments of this invention. Shown in FIG. 4a is the outside face ofsterilizing cabinet 100, vent 104, primary filter 108, secondary filter110, hinge 116, filter holder 106 section 402 which secures primaryfilter 108, and filter holder 106 section 404 which secures secondaryfilter 110. In this exemplary embodiment sections 402 and 404 are ableto rotate about hinge 116 and can be moved from the closed position(covering vent 104) to the open position (not covering vent 104)independent of each other. For instance section 404 can be moved to theopen position while section 402 remains in the closed position. However,in order for section 402 to move to the open position, section 404 mustalso be in the open position since it overlays section 402. Also shownin FIG. 4a are holes 406 on section 402, section 404 and on sterilizingcabinet 100. When section 402 and 404 are in the closed position, theholes 406 line-up such that a pin 118 or locking key can be insertedthrough the holes 406. This prevents sections 402 and 404 from openingduring a sterilization cycle or at any other time when opening would beundesirable.

In alternative exemplary embodiments sections 402 and 404 are maintainedor locked in the closed position through the use of a clamp or latch. Itcan be appreciated that exemplary embodiments of these teachings providefor any mechanism that allows sections 402 and 404 of filter holder 106to be maintained securely in the closed position and then opened whendesired.

FIG. 4b provides a perspective view of the movement of an alternativefilter arrangement of a sterilizing cabinet for use in practicingexemplary embodiments of this invention. Shown in FIG. 4b is the outsideface of sterilizing cabinet 100, vent 104, primary filter 108, hinge116, and filter holder 106 section 402, which secures primary filter108. It should be noted that in this exemplary embodiment, there is onlyone filter (i.e., primary filter 108) and one filter holder 106 section402. Here, filter holder 106 section 402 is able to rotate about hinge116. It can be moved from the closed position (covering vent 104) to theopen position (not covering vent 104). Also shown in FIG. 4b are holes406 on section 402. When section 402 is in the closed position, theholes 406 line-up such that a pin 118 or locking key can be insertedthrough the holes 406. This prevents section 402 from opening during asterilization cycle or at any other time when opening would beundesirable.

In alternative exemplary embodiments, section 402 is maintained orlocked in the closed position through the use of a clamp or latch. Itcan be appreciated that exemplary embodiments of these teachings providefor any mechanism that allows section 402 of filter holder 106 to bemaintained securely in the closed position and then opened when desired

FIG. 5a provides a perspective view of an alternative arrangement ofsterilization cabinet 100 with vents 104 on the sides of the cabinet. Inthis embodiment filter holders 110 are located on the sides ofsterilization cabinet 100 with primary filter 108 and secondary filter110. Also shown in FIG. 5a are hangers 502 from which filter holder 106,primary filter 108 and secondary filter 110 attach to sterilizingcabinet 100. It can be appreciated that exemplary embodiments ofsterilization cabinet 100 include vents 104, primary filter 108,secondary filter 110 and filter holder 106 on the side of sterilizationcabinet 100. As shown in FIG. 5a , the vents 104 define a venting passthrough area 140 of the sterilization cabinet 100. The sterilizationcabinet 100 as shown in FIG. 5a having a vent 104 on each side of thesterilization cabinet 100. For the 34 inch by 22 inch by 24 inchsterilization cabinet 100, the venting area at each end as shown in theFIG is 20 inch by 22 inch providing a venting area of 440 inch² and thetotal venting area is approximately 880 inch² as there are two vents 104having the same size in the configuration of the sterilization cabinetshown in FIG. 5a . The volume of the sterilization cabinet 100, whereinthe length is approximately 34 inches, the width is approximately 20,and the height is approximately 24 inches, is approximately 17,952inch³. Thus, the sterilization cabinet 100 as shown in FIG. 5a wouldhave a venting pass through area to volume ratio of approximately 0.049inch² per inch³, wherein the venting pass through area is approximately880 inch² compared to the volume, which is 17,952 inch³. In anotherconfiguration, the sterilization cabinet 100 includes 4 similarlydimensioned vents for the cabinet of 24 inches by 22 inches by 21inches, providing a venting pass through area of approximately 1760inch² compared a volume of approximately 11,000 inch³ providing aventing pass through area to volume ratio of approximately 0.16 inch²per inch³, or 4 square inches:25 cubic inches.

These high venting pass through area to volume ratios reduce the dryingtime required after the sterilization cycle. The sterilization cabinet100 can hold multiple trays holding instruments and, because of the highventing pass through area to volume ratio, have a drying time of lessthan 30 minutes, and more specifically, between 10-15 minutes, and evenmore specifically 10 minutes. These trays can each hold up to 25 lbs ofmaterial to be sterilized. In a configuration of the invention, the drytime of less than 30 minutes includes multiple trays loaded into thesterilization cabinet 100, the trays holding a total of 140 lbs or less.

FIG. 5b shows a front facing view of vent 104 with filter holder 106overlaying vent 104 on sterilizing cabinet 100. In this embodimentfilter holder 106 is sized such its edges completely cover the portionssurrounding vent 104. FIG. 5c shows primary filter 108 and filter holder106 overlaying vent 104. Primary filter 108 as shown hangs from hangers502 and attaches to filter holder 106 by clamps 504.

In yet another exemplary embodiment, as shown in FIGS. 6a-6c , thesterilization cabinet 100 includes sterilization cabinet frame 112, bars602 and hooks 604. In this configuration, there is no front side ofsterilization cabinet 100 in front of bars 602. It should be appreciatedthat exemplary embodiments of sterilizing cabinet 100 also includeembodiments of sterilization cabinet 100 that do not contain bars 602.In yet another exemplary embodiment of sterilization cabinet 100, bars602 are removeable such that bars 602 can be removeably affixed tosterilization cabinet 100 when desired. FIG. 6b illustrates filter door606 which contains primary filter 106. In exemplary embodiments filterdoor 606 covers the front opening of sterilizing cabinet 100 in FIG. 6a. Filter door 606 clamps onto sterilization cabinet 100 with clamps 608.Bars 602 prevent the contents of sterilization cabinet 100 (typically atray containing instruments for sterilization) from ripping or breakingprimary filter 108 and secondary filter 110.

FIG. 6c illustrates a second filter door 610, which attaches to filterdoor 606 and sterilizing cabinet 100 with the use of clamps 608. In thisconfiguration, it can be appreciated that clamps 608 on filter door 610fit into the spacing between clamps 608 on filter door 606. Thisarrangement prevents the clamps 608 from filter door 606 frominterfering with clamps 608 from filter door 610. Additionally, sincefilter door 610 is attached independently from filter door 606,secondary filter 110 can be removed with filter door 610 after asterilization cycle has completed without disturbing filter door's 606seal with sterilization cabinet 100. Each filter door 606, 610 includesa plurality of holes or openings 650 for the passage of sterilizingsteam or heat. Although holes or openings are shown, it should beappreciated that any type of opening can be used, including but notlimited to holes, slits, diamonds, or fenestrated openings as long asthe available area for the ingress and egress of a gas to and from theinterior volume of the sterilizing cabinet 100 provides the desiredventing pass through area to volume ratio. Further, it should beappreciated that, although the plurality of holes 650 of filter door 606and filter door 610 in the configuration shown in FIGS. 6b and 6c willalign, such alignment is not necessary. The venting pass through area tovolume ratio is based on the venting pass through area 140 of theprimary filter 108 and first door 606 and not both doors. It should beappreciated that the gas passing through the secondary filter 110 willbe dispersed into a flow path that may be different than the flow paththrough the holes 650 of the first door 606.

In this embodiment, filter door 606 forms a seal with sterilizationcabinet 100 at the edges of the open portion of the sterilizationcabinet frame 112, such that any sterilizing steam that enters or exitssterilizing cabinet 100 during a sterilization cycle must pass throughfilter door 606 and primary filter 106. Likewise, filter door 610 formsa seal with filter door 606 such that any sterilizing steam that exitssterilizing cabinet 100 and primary filter 108 must pass through filterdoor 610 and secondary filter 110. As shown in FIG. 6b , the filter door606 includes holes or openings 650 and defines a venting pass througharea 140 of the sterilization cabinet 100. The sterilizing cabinet 100as shown in FIG. 6b having 20 holes within the door 606 havingdimensions of approximately 34 inches by 24 inches includes a ventingpass through area of approximately 240 inch² based on each hole havingan area of approximately 12 inch². The total volume of the sterilizationcabinet 100, wherein the length is approximately 34 inches, the width isapproximately 22 inches, and the height is approximately 24 inches, isapproximately 17,952 inches³. Thus, the sterilization cabinet 100 asshown in FIG. 6b would have a venting pass through area to volume ratioof approximately 0.01 inch² per inch³.

Alternatively, for the sterilization container of FIG. 6b , being 24inch by 11 inch by 11 inch, the venting pass through area to volumeratio of approximately 0.08 inch² per inch³ is obtained, that is 2square inches per 25 cubic inches. Similarly, for the sterilizationcontainer of FIG. 6b , being 34 inch by 30 inch by 30 inch, the ventingpass through area to volume ratio of approximately 0.008 inch² per inch³is obtained.

Exemplary embodiments of sterilization cabinet 100 can include one ormore vents so long as the venting pass through area to volume ratio isequal to or greater than 0.008 inch² per inch³, or 1 square inch:125cubic inches, and in select configurations between 0.02-0.2 inch² perinch³, or between 1 square inch:50 cubic inches and 1 square inch:5cubic inches, and in further configurations between 0.16-0.2 inch² perinch³, or 4 square inches:25 cubic inches and 1 square inch:5 cubicinches.

The high venting pass through area to volume ratio reduces the dryingtime required after the sterilization cycle. The sterilization cabinet100 can hold multiple trays holding instruments and, because of theventing pass through area to volume ratio, have a drying time of lessthan 30 minutes, and more specifically, between 10-15 minutes, and evenmore specifically 10 minutes. In select configurations, the drying timecan be as little as 5 minutes. In one configuration, the sterilizationcabinet 100 holds up to 15 trays, each tray holding up to 25 lbs. In aconfiguration of the disclosure, the drying time of less than 30 minutesincludes multiple trays loaded into the sterilization cabinet 100, thetrays holding a total of 140 lbs or less.

FIG. 7a depicts a perspective view of the construction of thealternative arrangement sterilizing cabinet 100 from FIGS. 6a, 6b and 6c. As shown filter door 606 with clamps 608 attach around the frame ofsterilizing cabinet 100. Primary filter 108 is placed on top of filterdoor 606 and attaches to sterilizing cabinet 100 at hooks 604. Secondaryfilter 110 is placed on top of primary filter 108 and also attaches tosterilizing cabinet 100 at hooks 604. Filter door 610 is then placed ontop of secondary filter 110 and attached to sterilizing cabinet 100 withclamps 608. As illustrated in FIG. 7a , exemplary embodiments of filterdoors 606 and 608 contain numerous holes or openings along theirsurface, and allow for the passage of sterilizing steam. Exemplaryembodiments of filter doors 606 and 608 are able to be fully orpartially separable from sterilizing cabinet 100. It should also beappreciated that filter doors 606 and 608 can optionally employ the useof a hinge, clamp, clasp or the like as the mechanism for removing andreplacing filter doors 606 and 608 on sterilizing cabinet 100.

FIG. 7b depicts an alternative perspective view of the construction ofanother alternative arrangement sterilizing cabinet 100. As shown filterdoor 606 with clamps 608 attach around the frame of sterilizing cabinet100. Primary filter 108 is placed on top of filter door 606 and attachesto sterilizing cabinet 100 at hooks 604. In this embodiment, there isonly a single filter and no secondary filter. Primary filter 108 createsa sealed interface with filter door 606 such that extraneous materialscannot enter sterilizing cabinet 100. Filter door 610 is then placed ontop of primary filter 108 and attached to sterilizing cabinet 100 withclamps 608. In another exemplary embodiment, primary filter 108 does notcreate a sealed interface with filter door 606 until filter door 610 isplaced on top of primary filter 108 and filter door 606. In thisembodiment, a sealed interface between filter door 610 and primaryfilter 108, and a sealed interface between filter door 606 orsterilizing cabinet 100 and primary filter 108 is only created whenfilter door 610 is attached or affixed to sterilizing cabinet 100. Asillustrated in FIG. 7b , exemplary embodiments of filter doors 606 and608 which contain numerous holes or openings along their surface, whichallow for the passage of sterilizing steam.

It should be noted that exemplary embodiments of FIG. 7b provide thatfilter door 610 can be removed from sterilizing cabinet 100, primaryfilter 108 and filter door 606 without disturbing or disrupting thesealed interface between primary filter 108 and inter door 606. This winprevent the possibility of extraneous materials from enteringsterilizing cabinet 100 after a sterilizing cycle when filter door 610is removed in order to either allow primary filter 108 and filter door606 to be removed as well or for primary filter 108 to be inspected toverify that it maintained its integrity during the sterilizing cycle.

In an alternative exemplary embodiment, the sealed interface betweenfilter door 610 and primary filter 108, and the sealed interface betweenfilter door 606 or sterilizing cabinet 100 and primary filter 108 isbroken or can be broken when filter door 610 is removed from sterilizingcabinet 100, primary filter 108, and filter door 606. In yet anotherexemplary embodiment, the sealed interface between filter door 610 andprimary filter 108, and the sealed interface between filter door 606 orsterilizing cabinet 100 and primary filter 108 is only created andthereafter maintained when sterilizing cabinet 100 along with filterdoor 610, filter door 606 and primary filter 108 are exposed to asterilization cycle. Exemplary embodiments of sterilizing cabinet 100 asdepicted in FIG. 7b are able to maintain the sealed interface betweenfilter door 610 and primary filter 108, and the sealed interface betweenfilter door 606 or sterilizing cabinet 100 and primary filter 108 for anextended period of time following being exposed to a sterilizationcycle, such as sterilizing steam. For example, the sealed interface maybe able to remain intact for as long as 30-90 days. In other exemplaryembodiments the sealed interface may only remain intact for a matter ofhours.

Referring to FIGS. 8a, 8b and 8c , provided are different views of aspacer 802 for use in exemplary embodiments of sterilizing cabinet 100.In this embodiment spacer 802 has a wire frame and is sized such thatwhen it is placed inside sterilizing cabinet 100 it does not move. Thelength and width of spacer 802 closely matches the dimensions (i.e., thedepth and width) of the inside of sterilizing cabinet 100. This preventsspacer 802 from sliding or moving inside sterilizing cabinet 100 duringa sterilization cycle or while sterilizing cabinet 100 is being moved.It should be appreciated that spacer 802 is shaped such that there aredividers or lips 804 along the edges of spacer 802 and at spacer's 802midsection. The dividers or lips 804 are illustrated most clearly inFIGS. 8b and 8c . In practice, sterilizing trays can be placed on top ofspacer 802 prior to a sterilization cycle. In order to ensure that allof the contents of sterilizing cabinet 100 are sterilized, it isadvantageous to prevent sterilizing trays from touching. This canobscure portions of the sterilizing trays or their contents from thesterilizing steam. As such, the dividers or lips 804 provide a physicalbarrier between sterilizing trays creating a minimum separation betweenthe trays. This allows the passage sterilizing steam during asterilization cycle throughout sterilizing cabinet 100. Additionally,the dividers or lips 804 of spacer 802 are sized such that theyaccommodate the shape and size of sterilizing trays and thussubstantially prevent lateral movement (e.g., sliding) of sterilizingtrays when not desired before, during or following a sterilizationcycle.

FIGS. 9a, 9b and 9c illustrate an alternative spacer 902 for use insideexemplary embodiments of sterilizing cabinet 100. In this embodimentspacer 902 is made of thin sheets (e.g., metal or aluminum alloys) withholes 906 throughout the length of the sheets. In this embodiment spacer902 is sized such that when it is placed inside sterilizing cabinet 100it does not move. The length and width of spacer 902 closely matches thedimensions (i.e., the depth and width) of the inside of sterilizingcabinet 100. This prevents spacer 902 from sliding or moving insidesterilizing cabinet 100 during a sterilization cycle or whilesterilizing cabinet 100 is being moved. Spacer 902 is shaped such thatthere are dividers or lips 904 along the edges of spacer 902 andthroughout spacer's 902 mid-section. The dividers or lips 904 can beviewed most clearly in FIGS. 9b and 9c . In practice, sterilizing trayscan be placed on top of spacer 902 prior to a sterilization cycle. Inorder to ensure that all of the contents of sterilizing cabinet 100 aresterilized, it is advantageous to prevent sterilizing trays fromtouching. This can obscure portions of the sterilizing trays or theircontents from the sterilizing steam. As such, the dividers or lips 904provide a physical barrier between sterilizing trays creating a minimumseparation between the trays. This allows the passage sterilizing steamduring a sterilization cycle throughout sterilizing cabinet 100. Holes906 encompasses any variation of openings that allow for the passage ofsterilizing steam during a sterilization cycle yet maintainingstructural integrity of spacer 902 to carry the weight of thesterilizing trays and their contents.

Exemplary embodiments of spacers 802 and 902 provide for the spacer tobe fenestrated. In another exemplary embodiment spacers 802 and 902 arenot reusable but are disposable and can only be sterilized once. Inanother exemplary embodiment spacers 802 and 902 provide verticalspacing between trays by at least 0.1 to 5 inches. In yet anotherexemplary embodiment, spacers 802 and 902 provide vertical spacingbetween trays by at least 10 to 26 inches.

FIG. 10 provides an exemplary embodiment of a sterilizing tray forpracticing exemplary embodiments of this disclosure. For the purposes ofthis disclosure, the terms tray and pan are interchangeable and refer toan instrument with a closed rigid bottom and sides and an open top.Illustrated in FIG. 10 is sterilizing tray 1000 with an open top and aclosed rigid bottom and sides. Sterilizing tray 1000 can be made of anymaterial that can be sterilized (sterilizable) and is rigid enough suchthat it can hold items to be sterilized. For example sterilizing tray1000 can be made of metals or metal alloys. Exemplary embodiments ofsterilizing tray 1000 provide for a tray that has dimensions that makeit suitable for use with spacers 802 and 902 and sterilizing cabinet100. Exemplary embodiments of sterilizing tray 1000 also includes trayswith holes, slits, fenestrations or other openings that allow for thepassage of a sterilizing agent during a sterilization cycle.

In an exemplary embodiment in accordance of the present disclosure,spacers 802 or 902 can be used in conjunction with sterilizing cabinet100 and one or more sterilizing trays 1000 during a sterilization cycle.in this embodiment the one or more sterilizing trays 1000 are of theshape and size so that they can be retained within sterilizing cabinet100 and fit between the dividers 904 in spacers 902.

In practice, as shown in FIG. 11, a first tray is placed in sterilizingcabinet 100 on a spacer 902. On top of the first tray 1000 spacer 902 isthen placed. Next, a second tray 1000 is placed in sterilizing cabinet100 on top of spacer 902. The spacer 902 vertically separates the firsttray 1000 from the second tray 1000 in sterilizing cabinet 100. Spacer902 also inhibits lateral displacement of the first and second tray 1000through the use of the dividers and lips 904. The spacers 902 play theimportant role of allowing sterilizing steam to pass between thesterilizing trays 1000 during a sterilization cycle. It can beappreciated that exemplary embodiments include the addition of moresterilizing trays 1000 and spacers 902 arranged in accordance with thefirst and second sterilizing trays described. Exemplary embodiments ofspacers 902 provide space between the first and second tray 1000 by atleast 10 to 26 inches.

Exemplary embodiments of these teachings also provide for a sterilizablepan assembly for sterilization within sterilizing cabinet 100. Thesterilizable pan assembly as shown in FIG. 12 illustrates a firststerilizable pan 1202 with an open top and a closed bottom. Protrudingfrom the top of the first sterilizable pan 1202 are four legs 1204.Exemplary embodiments of the first sterilizable pan 1202 also includeslegs 1204 that protrude from the bottom of the first sterilizable pan1202. These legs are configured to releasably attach to a portion of asecond sterilizable pan 1206. Legs 1204 when attached to the secondsterilizable pan 1206 maintain a vertical spacing between the bottom ofthe first sterilizable pan 1202 and the top of the second sterilizablepan 1206. In one exemplary embodiment the vertical spacing is at least0.1 to 5 inches. In another exemplary embodiment, the vertical spacingis such that it allows for the passage of a sterilizing steam from asterilization cycle of sterilizing cabinet 100. Exemplary embodiments ofthis pan assembly are configured such that they can be used withinsterilizing cabinet 100 during a sterilization cycle.

Referring to FIG. 13a , provided is an exemplary embodiment of a filtersuitable for use in practicing exemplary embodiments of this disclosure.Shown in FIG. 13a is filter 1302 with a beaded edge 1304. Filter 1302can be made of any type of porous paper or cellulose type material. Inother embodiments, filter 1302 is made of polymeric substances, such aspolypropylene. Filter 1302 is required to be both porous and denseenough to allow the passage of a sterilizing agent, such as steam,through its membrane, but also resilient enough to not rip or tearduring a sterilizing cycle or during insertion clamping into a filterholder. In another embodiment, filter 1302 is both porous and lessresilient such that filter 1302 can be ripped or torn during use in asterilizing cycle or with filter holder 106. The beaded edge 1304creates a raised portion along the edges of the filter 1302 as shown inFIG. 13b . This enables filter 1302 to create a sealed interface whenused with sterilizing cabinet 100 and filter holder 106 over vents 104.in an alternative embodiment, beaded edge 1304 is placed inside the edgeof filter 1302 rather than on the edge of filter 1302 such that there isa space between the edge of filter 1302 and beaded edge 1304.

Exemplary embodiments of filter 1302 provide for filter 1302 to havedifferent densities along given cross-sections of the face of filter1302. For instance, filter 1302 may have a higher density along itsperiphery and a lower density towards its center. Exemplary embodimentsof filter 1302 also provide for filter 1302 to have differentthicknesses throughout its cross-section. The different thicknesses offilter 1302 provide different lengths of travel for sterilizing agents,which pass through filter 1302.

Exemplary embodiments of filter 1302 have a length and width thatcorresponds to the size of vents 104 of sterilizing cabinet 100 andfilter holder 106. Additionally, the thickness of beaded edge 1304corresponds to a size that is able to fit between sterilizing cabinet100 and filter holder 106 or between the different sections of filterholder 106. The thickness of beaded edge 1304 is also such that thesealed interface between sterilizing cabinet 100 and filter holder 106or between the different sections of filter holder 106 preventsextraneous materials from entering sterilizing cabinet 100 and forcesall of the sterilizing agent that enters and exits sterilizing cabinet100 to pass through filter 1302.

The beaded edge 1304 can be made of a silicone based material or anyother material that can create a sealed interface between sterilizingcabinet 100 or filter holder 106 and filter 1302. The beaded edge 1304also is required to be able to withstand high temperatures in excess of275 degrees without compromising its structural or chemical integrity.Exemplary embodiments of filter 1502 have a length and width thatcorresponds to the size of vents 104 of sterilizing cabinet 100 andfilter holder 106.

FIG. 14a provides an alternative exemplary embodiment of a filtersuitable for use in practicing exemplary embodiments of this disclosure.Shown in FIG. 14a is filter 1402 with folded edge 1404. Filter 1402 canbe made of any type of porous paper or cellulose type material. In otherembodiments filter 1402 is made of polymeric substances, such aspolypropylene. Filter 1402 is required to be porous enough to allow thepassage of a sterilizing agent, such as steam through its membrane, butalso resilient enough to not rip or tear during a sterilizing cycle orduring insertion/clamping into a filter holder 106. In anotherembodiment filter 1402 is both porous and less resilient such thatfilter 1402 can be ripped or torn during use in a sterilizing cycle orwith filter holder 106.

The folded edge 1404 is created by the edges of filter 1402 folded ontoitself thereby creating a thicker membrane along the edges of filter1402 as shown in FIG. 14b . The thicker membrane of folded edge 1404provides for a better-sealed interface between sterilizing cabinet 100and filter holder 106 as there is less likelihood that spaces can becreated between filter 1402 and sterilizing cabinet 100 which wouldallow for the passage of sterilizing steam or extraneous materials.Exemplary embodiments of filter 1402 have a length and width thatcorresponds to the size of vents 104 of sterilizing cabinet 100 andfilter holder 106.

Additionally, the thickness of folded edge 1404 corresponds to a sizethat is able to fit between sterilizing cabinet 100 and filter holder106 or between the different sections of filter holder 106. Thethickness of edge 1404 is also such that the sealed interface betweensterilizing cabinet 100 and filter holder 106 or between the differentsections of filter holder 106 prevents extraneous materials fromentering sterilizing cabinet 100 and forces all of the sterilizing agentthat enters and exits sterilizing cabinet 100 to pass through filter1402.

Referring to FIG. 15a , provided is another exemplary embodiment of afilter suitable for use in exemplary embodiments of this disclosure.Shown in FIG. 15a is filter 1502, filter edge 1504 and filter center1506. Filter 1502 can be made of any type of porous paper or cellulosetype material. In other embodiments filter 1502 is made of polymericsubstances, such as polypropylene. Filter 1502 is required to be porousenough to allow the passage of a sterilizing agent, such as steamthrough its membrane, but also resilient enough to not rip or tearduring a sterilizing cycle or during insertion/clamping into a filterholder 106. In another embodiment filter 1502 is both porous and lessresilient such that filter 1502 can be ripped or torn during use in asterilizing cycle or with filter holder 106.

Filter edge 1504 provides for a thicker portion of filter 1502 as shownin FIG. 15b . The thickness of filter edge 1504 enables filter 1502 tomake a better compressed sealed interface with sterilizing cabinet 100and filter holder 106. Exemplary embodiments of filter 1502 have alength and width that corresponds to the size of vents 104 ofsterilizing cabinet 100 and filter holder 106. Additionally, thethickness of edge 1504 corresponds to a size that is able to fit betweensterilizing cabinet 100 and filter holder 106 or between the differentsections of filter holder 106. The thickness of edge 1504 is also suchthat the sealed interface between sterilizing cabinet 100 and filterholder 106 or between the different sections of filter holder 106prevents extraneous materials from entering sterilizing cabinet 100 andforces all of the sterilizing agent that exits sterilizing cabinet 100to pass through center 1506 of filter 1502.

Center 1506 of filter 1502 includes all of the area of filter 1502 otherthan edge 1504 that is of normal or customary thickness for a filterthat allows the passage of sterilizing steam, but prevents the passageof other extraneous materials.

Shown in FIG. 16 is an exemplary filter cartridge 1600 suitable for usein practicing exemplary embodiments of this disclosure. FIG. 16 includesa separated view and a side view of filter cartridge 1600 in which thedifferent elements have been separated. niter cartridge 1600 includes aframe 1602 and filter 1604. Frame 1602 provides a substantially rigidframe that is substantially resistant from ripping or tearing. Frame1602 is typically made out of a cardboard or like material. Frame 1602can be made out of any type of material that is both substantially rigidand is able to maintain its integrity during and after undergoing asterilization cycle. Exemplary embodiments of frame 1602 can be made outof polymer based materials or cellulose based materials. In otherexemplary embodiments, frame 1602 is flexible and less rigid and maybecome deformed or shrink during a sterilization cycle. In anotherexemplary embodiment, frame 1602 can be made out of any type of materialthat is both flexible, less rigid and is able to maintain its integrityduring and after undergoing a sterilization cycle. In one exemplaryembodiment, frame 1602 is composed of medical grade light board. Inanother exemplary embodiment, frame 1602 is composed of a siliconematerial. Filter 1604 can be made of any type of porous paper orcellulose type material. In other embodiments filter 1604 is made ofpolymeric substances, such as polypropylene. Filter 1604 is required tobe porous enough to allow the passage of a sterilizing agent, such assteam through its membrane, but also resilient enough to not rip or tearduring a sterilizing cycle. Exemplary embodiments of filter cartridge1600 are able to provide sufficient integrity to form a sealed interfacewith a confronting surface, such as a sterilizing cabinet and/or afilter door or doors, and is able to maintain its integrity during andafter undergoing a sterilization cycle.

Exemplary embodiments of filter cartridge 1600 provide that frame 1602and filter 1604 are removeably coupled to each other through the use ofan adhesive. In another exemplary embodiment frame 1602 and filter 1604are not removeably coupled, but are permanently affixed to one anotheror are integral with one another. In yet another exemplary embodiment,frame 1602 and filter 1604 are removeably coupled to each other throughthe use of an intermediary adhesive, such as double sided tape or thelike. Exemplary adhesives are able to create a sealed interface betweenframe 1602 and filter 1604 and maintain the sealed interface betweenframe 1602 and filter 1604 prior to, during and following asterilization cycle. One exemplary adhesive suitable for use in filtercartridge 1600 is that found is U.S. Pat. No. 3,691,140. Exemplaryadhesives between frame 1602 and filter 1604 create a seal between frame1602 and filter 1604 such that extraneous materials are not able to passbetween the sealed interface of frame 1602 and filter 1604. Exemplaryadhesives between frame 1602 and filter 1604 allow for filter 1604 to beremoveable when desired, typically after undergoing sterilizing cycle,such that substantially all of filter 1604 can be removed in a singlepiece. That is, the adhesive and materials of frame 1602 and filter 1604are selected to provide for non-destructive separation of frame 1602 andfilter 1604.

Referring to FIG. 17, illustrated is filter cartridge 1700 suitable touse in practicing exemplary embodiments of this disclosure. FIG. 17includes a separated view and a side view of filter cartridge 1700 inwhich the different elements nave been separated. Filter cartridge 1700includes a frame 1702, filter 1704, and filter 1706. Frame 1702 providesa substantially rigid frame that is substantially resistant from rippingor tearing. In other exemplary embodiments, frame 1702 is flexible andless rigid and may become deformed or shrink during a sterilizationcycle. Frame 1702 is typically made out of a cardboard or like material.Frame 1702 can be made out of any type of material that is both rigidand is able to maintain its integrity during and after undergoing asterilization cycle. Exemplary embodiments of frame 1702 can be made outof polymer based materials or cellulose based materials. In anotherexemplary embodiment, frame 1702 can be made out of any type of materialthat is flexible, less rigid and is able to maintain its integrityduring and after undergoing a sterilization cycle. In one exemplaryembodiment, frame 1702 is composed of medical grade light board. Inanother exemplary embodiment, frame 1702 is composed of a siliconematerial.

Filter 1704 and filter 1706 can be made of any type of porous paper orcellulose type material. In other embodiments, filter 1704 and filter1706 are made of polymeric substances, such as polypropylene. Filter1704 and filter 1706 are required to be porous enough to allow thepassage of a sterilizing agent, such as steam through its membrane, butalso resilient enough to not rip or tear during a sterilizing cycle.Exemplary embodiments of filter cartridge 1700 are able to providesufficient integrity to form a sealed interface with a confrontingsurface, such as a sterilizing cabinet and/or a filter door or doors,and is able to maintain its integrity during and after undergoing asterilization cycle.

Exemplary embodiments of filter cartridge 1700 provide that frame 1702,is removeably coupled to filter 1704 and filter 1706 through the use ofan adhesive. In another exemplary embodiment frame 1702, filter 1704,and filter 1706 are not removeably coupled, but are permanently affixedto one another or are integral with one another. In yet anotherexemplary embodiment, frame 1702 is removeably coupled to filter 1704and filter 1706 through the use of an intermediary adhesive, such asdouble sided tape or the like. As shown in FIG. 17, filter 1704 andfilter 1706 are removeably coupled to frame 1702 such that they arelocated on opposing sides of frame 1702. Exemplary adhesives are able tocreate a sealed interface between frame 1702 and filter 1704, andbetween frame 1702 and filter 1706. One exemplary adhesive suitable foruse in filter cartridge 1700 is that found is U.S. Pat. No. 3,691,140.Exemplary adhesives are also able to maintain the sealed interfacebetween frame 1702 and filter 1704 prior to, during and following asterilization cycle, and between frame 1702 and filter 1706 prior to,during and following a sterilization cycle. Exemplary adhesives betweenframe 1702 and filter 1704 and between frame 1702 and filter 1706 createa seal between frame 1702 and filter 1704, and between frame 1702 andfilter 1706 such that extraneous materials are not able to pass betweenframe 1702 and filter 1704 or between frame 1702 and filter 1706.Exemplary adhesives between frame 1702 and filter 1704, and betweenframe 1702 and filter 1706 allow for filter 1604 and filter 1706 to beremoveable from frame 1702 when desired, typically after undergoingsterilizing cycle, such that substantially all of filter 1704 and filter1706 can be removed in a single piece.

Referring to FIG. 18, shown is an exemplary filter cartridge 1800suitable for use in practicing exemplary embodiments of this disclosure.FIG. 18 includes a separated view and a side view of filter cartridge1800 in which the different elements have been separated. Filtercartridge 1800 includes a frame 1802, frame 1804 and filter 1806. Frames1802 and 1804 provide a substantially rigid frame that is substantiallyresistant from ripping or tearing. Frames 1802 and 1804 are typicallymade out of a cardboard or like material. Frames 1802 and 1804 can bemade out of any type of material that is both substantially rigid and isable to maintain its integrity during and after undergoing asterilization cycle. Exemplary embodiments of frames 1802 and 1804 canbe made out of polymer based materials or cellulose based materials. Inother exemplary embodiments, frames 1802 and 1804 are flexible and lessrigid and may become deformed or shrink during a sterilization cycle. Inanother exemplary embodiment, frames 1802 and 1804 can be made out ofany type of material that is flexible, less rigid and is able tomaintain its integrity during and after undergoing a sterilizationcycle. In one exemplary embodiment, frames 1802 and 1804 are composed ofmedical grade light board. In another exemplary embodiment, frames 1802and 1804 are composed of a silicone material. Filter 1806 can be made ofany type of porous paper or cellulose type material. In otherembodiments filter 1806 is made of polymeric substances, such aspolypropylene. Filter 1806 is required to be porous enough to allow thepassage of a sterilizing agent, such as steam through its membrane, butalso resilient enough to not rip or tear during a sterilizing cycle.Exemplary embodiments of filter cartridge 1800 are able to providesufficient integrity to form a sealed interface with a confrontingsurface, such as a sterilizing cabinet and or a filter door or doors,and is able to maintain its integrity during and after undergoing asterilization cycle.

Exemplary embodiments of filter cartridge 1800 provide that frames 1802and 1804 are removeably coupled to filter 1806 through the use of anadhesive. In another exemplary embodiment frames 1802 and 1804, andfilter 1806 are not removeably coupled, but are permanently affixed toone another or are integral with one another. In yet another exemplaryembodiment, frames 1802 and 1804 are removeably coupled to filter 1806through the use of an intermediary adhesive, such as double sided tapeor the like. Exemplary adhesives are able to create a sealed interfacebetween frame 1802 and filter 1806, and between 1804 and filter 1806 andmaintain the sealed interface between frame 1802 and filter 1806, andbetween frame 1804 and filter 1806 prior to, during and following asterilization cycle. One exemplary adhesive suitable for use in filtercartridge 1800 is that found is U.S. Pat. No. 3,691,140. Exemplaryadhesives create a seal between frame 1802 and filter 1806, and betweenframe 1804 and filter 1806 such that extraneous materials do not passbetween frame 1802 and filter 1806, or between frame 1804 and filter1806. Exemplary adhesives between frame 1802 and filter 1806, andbetween frame 1804 and filter 1806 allow for filter 1806 to beremoveable when desired, typically after undergoing sterilizing cycle,such that substantially all of filter 1806 can be removed in a singlepiece.

Referring to FIG. 19, shown is an exemplary filter cartridge 1900suitable for use in practicing exemplary embodiments of this disclosure.FIG. 19 includes a separated view and a side view of filter cartridge1900 in which the different elements have been separated. Filtercartridge 1900 includes a frame 1902, frame 1904, filter 1906 and filter1908. Frames 1902 and 1904 provide a substantially rigid frame that issubstantially resistant from ripping or tearing. Frames 1902 and 1904are typically made out of a cardboard or like material. Frames 1902 and1904 can be made out of any type of material that is both substantiallyrigid and is able to maintain its integrity during and after undergoinga sterilization cycle. In other exemplary embodiments, frames 1902 and1904 are flexible and less rigid and may become deformed or shrinkduring a sterilization cycle. Exemplary embodiments of frames 1902 and1904 can be made out of polymer based materials or cellulose basedmaterials. In another exemplary embodiment, Frame 1902 and 1904 can bemade out of any type of material that is flexible, less rigid and isable to maintain its integrity during and after undergoing asterilization cycle. In one exemplary embodiment, frames 1902 and 1904are composed of medical grade light board. In another exemplaryembodiment, frames 1902 and 1904 are composed of a silicone material.Filters 1906 and 1908 can be made of any type of porous paper orcellulose type material. In other embodiments filters 1906 and 1908 aremade of polymeric substances, such as polypropylene. Filters 1906 and1908 are required to be porous enough to allow the passage of asterilizing agent, such as steam through its membrane, but alsoresilient enough to not rip or tear during a sterilizing cycle.Exemplary embodiments of filter cartridge 1900 are able to providesufficient integrity to form a sealed interface with a confrontingsurface, such as a sterilizing cabinet and or a filter door or doors,and is able to maintain its integrity during and after undergoing asterilization cycle.

Exemplary embodiments of filter cartridge 1900 provide that frames 1902and 1904 are removeably coupled to filters 1906 and 1908 through the useof an adhesive. In another exemplary embodiment frames 1902 and 1904,and filters 1906 and 1908 are not removeably coupled, but arepermanently affixed to one another or are integral with one another. Inyet another exemplary embodiment, frames 1902 and 1904 are removeablycoupled to filters 1906 and 1908 through the use of an intermediaryadhesive, such as double sided tape or the like. Exemplary adhesives areable to create a sealed interface between frame 1902 and filter 1906,between frame 1904 and filter 1906, between frame 1904 and filter 1908and also maintain the sealed interface between frames 1902 and 1904, andfilters 1906 and 1908 prior to, during and following a sterilizationcycle. One exemplary adhesive suitable for use in filter cartridge 1900is that found is U.S. Pat. No. 3,691,140. Exemplary adhesives betweenframes 1902 and 1904, and filters 1906 and 1908 create a seal betweenframes 1902 and 1904, and filter 1906 and 1908 such that extraneousmaterials do not pass between frames 1902 and 1904, and filters 1906 and1908. Exemplary adhesives between frames 1902 and 1904, and filters 1906and 1908 allow for filters 1906 and 1908 to be removeable from frames1902 and 1904 when desired, typically after undergoing sterilizingcycle, such that substantially all of filters 1906 or 1908 can beremoved in a single piece.

In another exemplary embodiment, as shown in FIGS. 20-25, thesterilization cabinet 2202, 2502, 2602, is a rigid container having anenclosing wall such as a plurality of walls and a door 2002, 2100, 2204,2304, 2512, and 2612 defining an interior volume. The sterilizationcabinet 2202, 2502, 2602, further includes at least one wall or doordefining a venting pass through area 140. A filter 2510, 2306, 1302,1402, 1502, 1602, and 1700 may occlude the venting pass through area140. The sterilization cabinet 2202, 2502, and 2602 is constructed of304 stainless steel with an anodized aluminum filter housing/door. Thesterilization container 2202, 2502, 2602, however, can be constructed ofother types of stainless steel, or other types of materials as well.

The sterilization cabinet 2202, 2502, 2602 may have a fenestrated door2506, 2612 holding a filter 2510, 2306, 1302, 1402,1502, 1602, 1700. Inone configuration, the filter 2510, 2306, 1302, 1402, 1502, 1602, 1700is a single-use filter. The sterilization cabinet 2202 2502, 2602 isdesigned to be used in a steam autoclave and may hold multiple opentrays containing surgical instruments. Trays within the container 2202,2502, 2602 may be separated by spacers 902 having dividers or lips 904along the edges of spacer 902 and throughout the midsection of spacer902 to ensure separation and maximum steam exposure. The sterilizationcabinet 2202, 2502, and 2602 has been validated to sterilize 375 lbs. ofinstruments along with the spacers 902. The validation was conductedwith 15 instrument trays at 25 lbs. Actual expected loads in hospitalsettings are likely to be less. For example, loads in a hospital settingare more typically 140 lbs or less, and even more typicallyapproximately 110 lbs. It should be appreciated that sterilizedinstruments can be stored for up to 30 days within the closed (intactfilters) sterilization container.

The sterilization cabinet 2202, 2502, 2602 is loaded into thesterilizer, for example, an autoclave, with a transfer carriage (notshown).

The use of a single-use disposable filter cartridge 1302, 1402, 1502,1602, 1700 installed in the fenestrated door 2506, 2612 eliminates theneed for a sealed gasket found on prior systems. The omission of areusable gasket eliminates contamination risks due to failed reusablegaskets. It is understood the single use disposable filter can be usedwith a separate or integral cartridge.

The sterilization cabinet 2202, 2502, 2602 is indicated for enclosingother medical devices that are to be sterilized by a healthcareprovider. It is intended to allow sterilization of the enclosedmaterials and maintain sterility for up to 30 days until used. Thesterilization cabinet 2202, 2502, 2602 is intended to be used inpre-vacuum steam sterilizers with a prevacuum cycle of 270° F. (132° C.)and exposure time of 4 minutes. The sterilization cabinet 2202, 2502,2602 is intended to be used with Turbett Surgical filters.

Validation was done using three trays per level and a maximum instrumentload of 25 lbs. per tray. The validation load included six 1 mm×500 mmlumens and six 3 mm×400 mm lumens. The total weight of instruments andtrays validated is 375 lbs. The trays holding instruments within thesterilizing cabinet 100 were uncovered, perforated or wire mesh generaldelivery trays.

The principal material of construction of the sterilization cabinet2202, 2502, 2602 may be stainless steel and aluminum. However, it shouldbe appreciated that other materials may be used. In one configuration,the overall size is 34″×24″×22″. The empty container 210 weighsapproximately 136 lbs. It is thus a relatively large container,typically associated with a transfer cart. In this configuration, theventing pass through area includes 905 holes, each having a diameter ofapproximately 0.74 inches, thus providing a venting pass through area of398.2 (approximately 400) square inches. Thus, in an exemplaryembodiment, the where the volume is approximately 17,952, cubic inchesbased on the overall size, the venting pass through area to volume ratiois approximately 0.022 inch² per inch³ or 11 square inches:500 cubicinches. If internal dimensions provide a volume of approximately 14,846cubic inches, the venting pass through area to volume ratio isapproximately 0.027 inch² per inch³ or 27 square inches:1000 cubicinches. It should be appreciated that exemplary embodiments of thesterilization cabinet can be other dimensions, shapes and sizes thatprovide similar vent to volume ratios, wherein the ratio is at leastapproximately 0.022 inch² per inch³ or 11 square inches:500 cubicinches, and in select configurations between 0.008-0.21 inch² per inch³,(1 square inch:125 cubic inches and 21 square inches:100 cubic inches)and in further configurations, between 0.16-0.2 inch² per inch³ (4square inches:25 cubic inches and 1 square inch:5 cubic inches). Thatis, the sterilization container, such as the cabinet may be configuredof any shape or size so long as the venting pass through area hasdimensions corresponding to the volume to provide the desired vent areato volume ratio. Similarly, the venting area may have many shapes, sizesand/or locations on the sterilization cabinet, so long as the ventingarea and volume meet the vent pass through area to volume ratios.

Referring to FIG. 20, shown is an exemplary filter door for a filtercartridge suitable for use in practicing exemplary embodiments of thisdisclosure. Shown in FIG. 20 is an exemplary outer filter door 2002.Filter door 2002 includes tabs or catches 2004, which protrudeperpendicular from the back face of filter door 2002. Filter door 2002as illustrated in FIG. 20 contains numerous holes or openings along itssurface, which allow for the passage of sterilizing steam. In theembodiment depicted in FIG. 20, the tabs or catches 2004 are located ineach of the four corners of filter door 2002. However, it should benoted that in other exemplary embodiments there can be more or less thanfour tabs or catches 2004. Additionally, tabs or catches 2004 can belocated in different arrangements. Exemplary tabs or catches 2004provide a mechanism for removeably locating or placing a filtercartridge on filter door 2002, such that a filter cartridge can beplaced between tabs or catches 2004 and is in contact with tabs orcatches 2004 without bending, folding or otherwise compromising theintegrity of a filter cartridge.

Referring to FIG. 21, shown is a magnified cross-sectional view of anexemplary sterilizing cabinet and filter door suitable for use inpracticing exemplary embodiments of this disclosure. Shown in FIG. 21 isa cross-sectional view of sterilizing cabinet 2102 with trough section2104, and filter door 2106 with trough section 2108. Exemplaryembodiments of trough section 2104 and trough section 2106 run along theentire edge of sterilizing cabinet 2102 and filter door 2106. Troughsection 2104 and trough section 2106 are shaped such that a sealedinterface is maintained throughout the trough (i.e., between troughsection 2104 and trough section 2106) when a single filter, multiplefilters, or a filter cartridge is placed between trough section 2104 andtrough section 2106. Exemplary embodiments of trough section 2104 andtrough section 2106 have a size and depth such that the movement ofextraneous materials through the sealed interface between sterilizingcabinet 2102 and filter door 2106 is substantially prevented. Inpractice, a filter cartridge may be placed and compressed between thesterilizing cabinet 2102 and filter door 2106 such that the filtercartridge is deformed into the shape of the trough in which it iscompressed.

Referring to FIG. 22, shown is a perspective view of an exemplarysterilizing cabinet and filter door suitable for use in practicingexemplary embodiments of the present disclosure. Illustrated in FIG. 22is sterilizing cabinet 2202, filter door 2204, trough section 2206,sterilizing cabinet tab 2208, filter door pin 2210, pin hole 2212, andclamp 2214. Exemplary embodiments of filter door pin 2210 are located onthe top two corners of filter door 2204. In other exemplary embodiments,filter door pins 2210 are located at all four corners of filter door2204. Filter door pins 2210 are of the size and shape to fit within pinhole 2212. Exemplary embodiments of filter door pin 2210 and pin hole2212 are located such that filter door 2204 properly aligns and coversthe open front of sterilizing cabinet 2202. Exemplary embodiments offilter door pin 2210 and pin hole 2212 maintain filter door 2204 is aloosely attached position to sterilizing cabinet 2202.

In other exemplary embodiments, filter door 2204 with filter door pin2210 aligns with pin holes 2212 on sterilizing cabinet 2202 such thatthere is a small gap between the edge 2216 of sterilizing cabinet 2202and filter door 2204. It can be appreciated that pin hole 2212 islocated on sterilizing cabinet tab 2208. Exemplary embodiments ofsterilizing cabinet tab 2208 are located at least in the four corners ofsterilizing cabinet 2202 along edge 2216. In other exemplaryembodiments, a sterilizing cabinet tab 2208 is also located within themiddle of the vertical and horizontal edge 2216 of sterilizing cabinet2202 such that there are eight (8) sterilizing cabinet tabs 2208. Inanother exemplary embodiment sterilizing cabinet 2202 includes one ormore sterilizing cabinet tab 2208. Exemplary embodiments of sterilizingcabinet tab 2208 overlap with filter door 2204 when placed over thefront opening of sterilizing cabinet 2202 such that filter door 2204 isprevented from falling or moving into the interior of sterilizingcabinet 2202 when filter door 2204 is aligned with pin hole 2212.

FIG. 22 also shows clamp 2214. Exemplary embodiments of clamp 2214 arelocated on the vertical sides of sterilizing cabinet 2202. However,exemplary embodiments of clamp 2214 can be placed in many differentarrangements along the sides of sterilizing cabinet 2202 such thatclamps 2214 are able to clasp and maintain filter door 2204 in a sealedposition over the open front of sterilizing cabinet 2202. Exemplaryembodiments of clamps 2214 are able to clasp and release filter door2204 and an outer filter door from sterilizing cabinet 2202. Exemplaryembodiments of clamp 2214 are sized such that a sealed interface iscreated between sterilizing cabinet 2202, a filter or filters, and thefilter doors. The sealed interface prevents the passage of extraneousmaterials between the filter doors and sterilizing cabinet 2202.

With reference to FIG. 23, shown is a perspective view of an exemplarysterilizing cabinet and filter door suitable for use in practicingexemplary embodiments of the present disclosure. Shown in FIG. 23 aresterilizing cabinet 2302, filter door 2304, filter cartridge 2306, clamptrough 2308, and clamp 2310. As illustrated, filter door 2304 includesclamp trough 2308 around the outer edge of filter door 2304. Exemplaryembodiments of clamp trough 2308 align with the trough section ofsterilizing cabinet 2302 when filter door 2304 covers the opening ofsterilizing cabinet 2302. Additionally, clamp trough 2308 is sized andlocated such that clamp 2310 is able to latch, clamp or otherwise hookonto filter door 2304 through clamp trough 2308. Exemplary embodimentsof clamp trough 2308 provides a lip or trough that substantiallyprevents clamp 2310 from slipping when clamp 2310 clamps onto filterdoor 2304.

Referring to FIG. 24, shown is a bottom perspective view of an exemplarysterilizing cabinet suitable for use in practicing exemplary embodimentsof the present disclosure. Shown in FIG. 24 are sterilizing cabinet2402, sterilizing cabinet tabs 2404, clamp 2406 and legs 2408. Exemplaryembodiments of legs 2408 reside on the bottom of sterilizing cabinet2402 and provide a stable foundation for sterilizing cabinet 2402 torest on a surface. Exemplary embodiments of legs 2408 further includeholes 2410. Holes 2410 provide a means for attaching legs 2408 and thussterilizing cabinet 2402 to a surface. For example, sterilizing cabinet2402 through holes 2410 on legs 2408 can be screwed, bolted, attached,or nailed onto a table, counter, or other flat surface large andstructurally sturdy enough to maintain sterilizing cabinet 2402.

Referring to FIG. 25, shown is a perspective view or an alternativeembodiment of a sterilizing cabinet suitable for use in practicingexemplary embodiments of this disclosure. Shown in FIG. 25 aresterilizing cabinet 2502, frame 2504, filter door 2506, latches 2508,and filter 2510. As illustrated, sterilizing cabinet 2502 is maintainedwithin frame 2504. Frame 2504 provides a structurally reinforcing framefor sterilizing cabinet 2502. Exemplary embodiments of frame 2504 areable to securely maintain sterilizing cabinet 2502 such that all of thesides/corners of sterilizing cabinet 2502 are supported by frame 2504.Exemplary embodiments of frame 2504 are made of any type of metal,plastic, composite, or aluminum alloy. Exemplary embodiments of frame2504 are able to repeatedly undergo sterilizing cycles (e.g., steamsterilizing cycles) and maintain its structural integrity.

Filter door 2506 attaches to frame 2504 through the use of latches 2508.However, it should be appreciated that latches 2508 can include any typeof clamping, latching or clasping device known in the art that is ableto releasable attach filter door 2506 to frame 2504 such that a sealedinterface is created between filter door 2506 and sterilizing cabinet2502.

Referring to FIG. 26, shown is a perspective view of a separatedalternative embodiment of a sterilizing cabinet suitable for use inpracticing exemplary embodiments of this disclosure. Shown in FIG. 26are sterilizing cabinet 2602, frame 2604, filter door 2606, filtercartridge 2608, and latches 2610. In some embodiments, as shown in FIG.26, sterilizing cabinet 2602 can be removed from frame 2604 when filterdoor 2606 is released from removable frame 2604 by latches 2610. Inother exemplary embodiments, frame 2604 is not removable fromsterilizing cabinet 2602, but is fixedly attached to sterilizing cabinet2602. Filter door 2606 as depicted includes a fenestrated gridthroughout its center. However, exemplary embodiments of filter door2606 include any type of arrangement of holes, gaps, or grids such thatsterilizing steam is free to pass through the center portion of filterdoor 2606.

During a sterilizing cycle filter cartridge 2608 is maintained betweenfilter door 2606 and sterilizing cabinet 2602. As previously statedabove, filter cartridge 2608 is placed between filter door 2606 andsterilizing cabinet 2602 creating a sealed interface around its edgessuch that sterilizing steam is not able to pass between the sealedinterface, but can only pass through the center of filter cartridge2608.

Technological Characteristics:

The sterilization cabinet 2202, 2502, 2602 has been validated tosterilize 375 lbs. of instruments along with the spacers 902. Thevalidation was conducted with 15 instrument trays at 25 lbs. each torepresent the most challenging case. The validations included thermalprofile, sterilization efficacy, and drying in a pre-vacuum steamsterilizer. Sterilized instruments can be stored for up to 30 dayswithin the closed container.

The sterilization cabinet 2202, 2502, 2602 is constructed of 304stainless steel sheet metal on a rigid stainless steel frame. Thesterilization container, such as the cabinet opens from the side foreasy placement and retrieval of surgical trays. In one configuration, asidewall is omitted to define a door way or opening to the cabinet forinserting and removing trays (medical instruments). A filter 1700comprised of 1 or 2 layers of filter paper 1704, 1706 and a compressiblegasket 1702 is placed between the door and the cabinet, such that aportion of the filter or gasket is disposed between the door and thecabinet to form a sealed interface. After use (the sterilization processand removal of the trays (the sterilized medical instruments), thefilter 1700 having the compressible gasket 1702 is discarded.

The following testing was conducted to establish substantial equivalenceand efficacy:

-   -   ANSI/AAMI ST77: Containment Devices for Reusable Medical Device        Sterilization testing:        -   Pre-vacuum thermal profile        -   Steam pre-vacuum sterilization efficacy        -   Pre-vacuum dry time        -   Microbial aerosol challenge        -   30 day shelf-life study    -   AAMI TIR 30: A Compendium of Processes, Materials, Test Methods        and Acceptance Criteria for Cleaning Reusable Medical Devices        testing:        -   Protein analysis and Total Organic Carbon Manual cleaning            methods    -   ANSI/AAMI HE75: Human Factors Engineering—Design of Medical        Devices testing:        -   Human factors usability study

Turning now to FIG. 25, the sterilization cabinet 2202 includes door2204 having a large vented area 2512. In one configuration, the ventingpass through area of the door 2204 includes a plurality of holes or afenestrated grid throughout its center. For example, the venting passthrough area 2512 of the door 2204 includes approximately 461 holes,each having an area of approximately 0.82 square inches, thus providinga venting pass through area 2512 of 377 inch². The sterilization cabinet2202 having an interior volume of approximately 17,952 inch³ would thus,have a venting pass through area of 377 inch² compared to a volume of17,952 inches³, or a ratio of approximately 0.021 inch² per inch³ or 21square inches:1000 cubic inches.

Exemplary embodiments of sterilization cabinet 2202 can include a singlevent or a plurality of vents to define the venting pass through area, solong as the venting pass through area to volume ratio between 0.008-0.21inch² per inch³ (or 1 square inch:125 cubic inches and 21 squareinches:1000 cubic inches) and in select configurations between 0.16-0.21inch² per inch³ (or 4 square inches:25 cubic inches and 21 squareinches:1000 cubic inches), or in further configurations equal to orgreater than 0.021 inch² per inch³ or 21 square inches:1000 cubicinches.

The high venting pass through area to volume ratio reduces the dryingtime required after the sterilization cycle. That is, assuming multipletrays of medical instruments in a sterilization cabinet 100, forexample, up to 15 trays, are placed in a sterilizer device, such as anautoclave, the sterilization cabinet 2202, with the venting pass througharea to volume ratio of 0.021 per inch, would require a dry time of lessthan 30 minutes, and more specifically approximately 10-15 minutes, andeven more specifically, 10 minutes. In one configuration, a dry time ofless than 15 minutes is provided when a ratio of the venting passthrough area to the interior volume of the sterilization cabinet 2202 isbetween 0.008-0.21 inch² per inch³ (or 1 square inch:125 cubic inchesand 21 square inches:1000 cubic inches). In another configuration, thedrying time is approximately 10 minutes for up to 140 lbs of medicalinstruments arranged in the sterilization cabinet 2202 on multipletrays.

In one configuration, the sterilization container has dimensions ofapproximately 34 inch by 22 inch by 24 inch and the door has 869 holesat 0.766″ diameter and 32 holes at 0.5″ diameter. Thus, the vented passthrough area is 400 inch² plus approximately 6 inch². Thus, the ratio ofthe venting pass through area to the interior volume of thesterilization cabinet is approximately 406 inch² to 17952 inch³ or0.0226 inch² per inch³.

As shown in FIGS. 27 and 28, the sterilization cabinet 3000 includes aplurality of sidewalls 3002 and a door (not shown). The sterilizationcabinet 3000 can hold multiple trays for holding medical instruments. Inone configuration, the sterilizing cabinet 3000 can hold up to 15 trays.At least one of the sidewalls 3002 includes a large vented area. Forexample, as shown in FIGS. 27 and 28, walls 3002 include a ventedportion 3008 along the lower portion of the walls and a vented portionalong top walls 3006. The vented portion 3008 may include a large vent,or multiple vents of any shape and size that provide the venting passthrough area to volume ratio. In one configuration, the vented portion3008 includes rectangular vents along a lower portion of the sidewalls3002 and smaller oval or circular vents along top wall 2006. It shouldbe appreciated that the vents 2008 along the lower portion of walls 3002may permit drainage of condensate to further decrease the amount of drytime required during the sterilization process.

In one configuration, the total venting pass through area 3008 of thesidewalls 3002 and top wall 3006 to the interior volume of thesterilization cabinet 3000 ratio is greater than 0.008 inch² per inch³.The high venting pass through area to volume ratio is sufficient toprovide a dry time of 30 minutes or less, and more preferably 15minutes, and even more preferably 10 minutes. In one configuration,these drying times are achieved when 140 lbs of medical instruments areloaded on trays in the sterilization cabinet 3000. The venting passthrough areas 3008 of the sterilization cabinet 3000 may be smaller orlarger, of a different shape, or provided on a different location of thesidewalls, top wall, bottom wall, and/or door, or include a plurality ofholes or a fenestrated grid throughout its center, provided, however,that the venting pass through area to volume ratio is greater than 0.008inch² per inch³ (or 1 square inch:125 cubic inches).

Referring to FIG. 29, illustrated is a side view of an embodiment of asterilizing cabinet in an autoclave 10. Shown in FIG. 29 is asterilizing cabinet 2702 with bottom 2704, front legs 2706, and backlegs 2708. Front legs 2706 and back legs 2708 as shown in FIG. 29 arepegs or stands fixedly attached to bottom 2704 of sterilizing cabinet2702, which provide support for sterilizing cabinet 2702 when placed ona substantially planar surface. As shown in FIG. 29, there are two frontlegs 2706 and two back legs 2708. However, it should be appreciated thatexemplary embodiments of front legs 2706 and back legs 2708 can includeone or more than one leg or support provided that front legs 2706 areshorter than back legs 2708 which in turn tilts or angles bottom 2704toward the front of sterilizing cabinet 2702. In other words, front legs2706 and back legs 2708 include any arrangement resulting in bottom 2704not being a level surface but tilted, inclined, towards a vent port ofsterilizing cabinet 2702. Preferably, the bottom 2704 is sufficientlyinclined to induce a flow of condensate to and through the vent port.

In another exemplary embodiment, sterilizing cabinet 2702 includes asingle front leg 2706 that spans or substantially spans the front widthof sterilizing cabinet 2702, and a single back leg 2708 that spans orsubstantially spans the back width of sterilizing cabinet 2702. in yetanother embodiment, sterilizing cabinet 2702 includes two front legs2706 located in opposite front corners of bottom 2704 of sterilizingcabinet 2702, and a single back leg 2708 located in the middle orsubstantially the middle of the back of bottom 2704 of sterilizingcabinet 2702.

In a further exemplary embodiment, front legs 2706 and back legs 2708are adjustable such that their length or height can be manually changed.It is contemplated that sterilizing cabinet 2702 can include actuators,such as servos, pistons, or lifts that can be remotely engaged to tiltthe bottom 2704 to selectively induce flow along the bottom to the ventport.

Exemplary embodiments of bottom 2704 provide a flat surface that whentilted, towards the front of sterilizing cabinet 2702 which contains avent port and a filter, allows a liquid, such as condensate to flowalong bottom 2704 to and through the filter and out of sterilizingcabinet 2702. In practice, when sterilizing cabinet 2702 undergoes asterilization cycle, sterilizing cabinet 2702 is placed in an autoclaveor other known sterilizing device. The autoclave is then shut andsterilizing steam passes through a filter or filters overlaying a frontvent port to the interior of sterilizing cabinet 2702 at which point thesterilizing steam comes into contact with any items or materials withinthe interior of sterilizing cabinet 2702. This process can produce asubstantial amount of condensate within the interior of sterilizingcabinet 2702, which can collect on the bottom 2704 of sterilizingcabinet 2702. For example, approximately 12 ounces of condensate may beproduced for every 15 pounds of load maintained within sterilizingcabinet 2702 during a sterilization cycle of the autoclave. Exemplaryembodiments of bottom 2704 provide a surface that allows the condensateto flow or move freely towards a filter on sterilizing cabinet 2702,such as the front of the cabinet, so that the condensate can exit theinterior of sterilizing cabinet 2702. Exemplary embodiments of thesterilizing cabinet 2702 further provide for at least a substantialportion, and in select configurations all of the condensate withinsterilizing cabinet 2702 to have exited sterilizing cabinet 2702 priorto the opening of the autoclave 10 or other sterilizing device. In yetanother exemplary embodiment, sterilizing cabinet 2702 contains anindustry acceptable amount of condensate following a sterilizing cycle,when the autoclave is opened.

Exemplary embodiments of bottom 2704 also include surfaces that are notsubstantially flat, but have channels, features or minor curves thatmove or allow to move condensate or accumulated condensate to a ventport of sterilizing cabinet 2702 through a filter or to anotherpredetermined outlet or filtered drain that exits the interior ofsterilizing cabinet 2702.

Shown in FIG. 30 is sterilizing cabinet 2802, bottom 2804, front legs2806, back legs 2808, and raised floor 2810 within the autoclave 10. Inthis embodiment, front legs 2806 and back legs 2808 are the same lengthor height such that bottom 2804 as well as sterilizing cabinet 2802 islevel when placed on a level planar surface. Raised floor 2810 asdepicted is located above bottom 2804 in the interior or sterilizingcabinet 2802.

Raised floor 2810 in one embodiment is substantially planar. Exemplaryembodiments of raised floor 2810 provide a surface that allows or movesa flow of condensate toward a vent port located on the front ofsterilizing cabinet 2802 and through the filter overlying the vent port.In another exemplary embodiment, raised floor 2810 is a surface that isnot substantially planar, but is curved or has minor curves, or flowchannels that moves or allows to move a flow of condensate oraccumulated condensate to a vent port of sterilizing cabinet 2802 or toanother predetermined outlet or filtered drain that exits the interiorof sterilizing cabinet 2802.

Shown in FIG. 31 is the interior of sterilizing cabinet 2802 with bottom2804, and raised floor 2810 within the autoclave 10. As is shown, raisedfloor 2810 is above bottom 2804 and is angled relative to bottom 2804such that a flow of condensate is directed toward the vent port ofsterilizing cabinet 2802. It should be appreciated that exemplaryembodiments of raised floor 2810 can include both substantially planarand curved or featured (with channels) embodiments that directcondensate toward a vent port on sterilizing cabinet 2802, or towardanother outlet that allows condensate to drain or exit the interior ofsterilizing cabinet 2802.

Shown in FIG. 32 is sterilizing cabinet 2802, bottom 2804, raised floor2810, raised floor supports 2812, and vent port 2814 within theautoclave 10. Raised floor supports 2812 provide support for theposition of raised floor 2810 with sterilizing cabinet 2802. As shown inFIG. 32, raised floor supports 2812 are beams located under raised floor2810 that are connected to raised floor 2810 and bottom 2804 to maintainthe position of raised floor 2810. It should be appreciated that raisedfloor supports 2812 can include any known beam or support that is ableto maintain the position of raised floor 2810 with the weight of theanticipated loaded sterilizing cabinet 2802, which can be up to a 250pound load or more.

As illustrated in FIG. 32, raised floor 2810 is flush with the bottom ofvent port 2814. Exemplary embodiments of raised floor 2810 includeinstances wherein raised floor 2810 is flush or nearly flush with thebottom of vent port 2814. Exemplary embodiment of raised floor 2810 arepositioned relative to the bottom of vent port 2814 such that a flow ofcondensate along raised bottom 2810 can move and progress through ventport 2814. Raised floor 2810 in the embodiment shown, is tilted orangled relative to bottom 2804 toward vent port 2814 such that any fluidor condensate on raised floor 2810 is moved towards vent port 2814.

In operation, the autoclave receives the sterilizing cabinet andsubjects the sterilizing cabinet to a sterilization cycle. As set forthabove, the sterilization can include, but is not limited to heat, steam,pressure, gas, plasma, irradiation, chemical components, chemical vaporor combinations thereof.

Thus, the sterilizing cabinet is retained within the autoclave, and theinterior environment of the autoclave is controlled to provide asterilization cycle. The autoclave typically creates a sealedenvironment which is thus applied to the retained sterilizing cabinet.The autoclave thus subjects the sterilizing cabinet and the interior ofthe sterilizing cabinet to the sterilization cycle.

The interface between the filters and the sterilizing cabinet iseffectively sealed either prior to or during or at the completion of thesterilization cycle. That is, at least before the autoclave is opened, asealed interface is formed between the seals and the sterilizingcabinet. It is understood the seal between the filter and thesterilizing cabinet may go through a transformation during thesterilization cycle. When the filter is initially operably locatedrelative to the sterilizing cabinet, a seal can be formed. However, itis contemplated that the initial operable location of the seal relativeto the sterilizing cabinet may not form a seal, wherein the sealedinterface is formed during the sterilization cycle or at the completionof the sterilization cycle.

The seal, when exposed to the sterilization cycle, (in select cases,heat in the form of steam, and pressure) may under goes slighttransformation of the seal configuration, and either becomes more formfitting to the sealing surface area or even results in seal formation.This change in the seal during the sterilization cycle may create a morerobust seal than when it was originally placed. It is contemplated avariety of materials can be used to enhance or form a seal between thefilter (or the cartridge) and the sterilizing cabinet, such as but notlimited to card stocks, thermoplastics, thermoplastic elastomers,polymers and waxes.

Thus, the interface between the filters and the sterilizing cabinet canbe dynamic, forming a seal during the sterilization cycle, or static,entering the sterilization cycle with the sealed interface andmaintaining the sealed interface throughout the sterilization cycle.

Before the autoclave is opened, that is before the sterilizedenvironment of the autoclave is exposed to ambient environment, theinterior of the sterilizing cabinet should have no more than a certainamount of moisture and a seal exist between any filter, or cartridge andthe sterilizing cabinet. Thus, it is advantageous for a sterilizingcabinet to have only an amount of condensate that can be driven off orevaporated by the autoclave during a normal, or given or predeterminedsterilizing cycle of the autoclave or during the post-sterilization cooldown period.

In conjunction with any cycle time for removing condensate, the inclinedsurface in the sterilizing cabinet induces a flow of the condensate toand through a port, such as a filter. The cycle time can be decreased byfacilitating the removal of condensate from the sterilizing cabinetduring the sterilization cycle. That is, by draining condensate from thesterilizing cabinet during the sterilization cycle, the amount ofcondensate to be evaporated from within the sterilizing cabinet duringthe sterilization cycle, or during the post-sterilization cool downperiod, is decreased, thereby increasing efficiency of the process.

Further exemplary embodiments according to this disclosure include thefollowing embodiments below. Embodiment 1: A sterilizing assembly,comprising: (a) a sterilizing cabinet; (b) a first tray and a secondtray sized to be retained within the cabinet; and (c) at least oneremovable spacer intermediate the first tray and the second tray, thespacer being sterilizable and vertically separating the first tray andthe second tray by a given height, the spacer inhibiting lateraldisplacement of the first tray relative to the second tray, wherein thegiven height is sufficient to permit a passage of a sufficient quantityof a sterilizing agent between the first tray and the second tray for apredetermined time.

Embodiment 2: The sterilizing assembly according to embodiment 1,wherein the at least one removable spacer is fenestrated.

Embodiment 3: The sterilizing assembly according to embodiment 1,further comprising a second removable spacer, the second removablespacer being sterilizable and located intermediate to one of the firsttray and the second tray and the sterilizing cabinet.

Embodiment 4: The sterilizing assembly according to embodiment 1,wherein the given height is at least 0.1 inches.

Embodiment 5: The sterilizing assembly according to embodiment 1,wherein the given height is sufficient to permit passage of asterilizing agent.

Embodiment 6: The sterilizing assembly according to embodiment 1,wherein the at least one removable spacer includes a shaped wire.

Embodiment 7: The sterilizing assembly according to embodiment 1,wherein the first tray defines an open top and the at least oneremovable spacer is sized to span the open top.

Embodiment 8: The sterilizing assembly according to embodiment 1,wherein the first tray is free of a lid.

Embodiment 9: The sterilizing assembly according to embodiment 1,wherein the at least one removable spacer and the second removablespacer are sterilizable only once.

Embodiment 10: A method of loading a sterilizing cabinet, the methodcomprising: (a) loading a sterilizable first pan and a sterilizablesecond pan within the sterilizing cabinet; and (b) placing a removableand sterilizable spacer between the first pan and the second pan, thespacer (i) providing at least one of a predetermined vertical spacingbetween the first pan and the second pan and (ii) inhibiting horizontaldisplacement of the first pan relative to the second pan.

Embodiment 11: The method according to embodiment 10, wherein at leastone of the first pan and the second pan is lid free.

Embodiment 12: The method according to embodiment 10, wherein thevertical spacing is sufficient to permit passage of a sterilizing agent.

Embodiment 13: The method according to embodiment 10, wherein thepredetermined vertical spacing is at least 0.1 inches.

Embodiment 14: The method according to embodiment 10, further comprisingloading a sterilizable third pan and a sterilizable fourth pan withinthe sterilizing cabinet and placing a second sterilizable spacer toindividually vertically space the sterilizable second pan relative tothe sterilizable third pan and placing a third sterilizable spacer toindividually vertically space the sterilizable third pan relative to thefourth pan independent of the first pan and the second pan.

Embodiment 15: The method according to embodiment 10, wherein thesterilizable spacer between the first pan and the second pan provides apredetermined vertical spacing between the first pan and the second pan.

Embodiment 16: A method of sterilizing, the method comprising: (a)loading a tray retaining a surgical instrument in a sterilizationcabinet; (b) sealing a primary filter relative to a vent port in thesterilization cabinet; (c) sealing a secondary filter relative to thevent port and independent of the primary filter; and (d) passing asterilizing agent through the secondary filter and the primary filter.For the purposes of this disclosure surgical instruments includesimplantable materials or devices as well as instruments used forconducting surgeries and medical procedures.

Embodiment 17: The method according to embodiment 16, further comprisingremoving the secondary filter to retain the sealed primary filter andsterilization cabinet.

Embodiment 18: A sterilizable pan assembly, comprising: (a) a firststerilizable pan having an open top, a closed bottom and a pair ofprojecting spacer legs; and (b) a second sterilizable pan having an opentop and a closed bottom, (c) the spacer legs configured to releasablyengage a portion of the second pan and maintain a predetermined verticalspacing between the bottom of the first pan and the top of the secondpan.

Embodiment 19: The sterilizable pan assembly according to embodiment 18,wherein the predetermined vertical spacing between the bottom of thefirst pan and the top of the second pan is at least 0.1 inches.

Embodiment 20: The sterilizable pan assembly according to embodiment 18,wherein the predetermined vertical spacing between the bottom of thefirst pan and the top of the second pan is sufficient to permit passageof a sterilizing agent.

Embodiment 21: A filtering assembly, comprising: (a) a primary filterholding portion for holding a primary filter for overlying a vent portand forming a sealed interface with a sterilizing cabinet; and (b) asecondary filter holding portion for holding a secondary niter, moveablyattached to the primary filter holding portion for overlying the primaryfilter holding portion and forming a sealed interface with the primaryfilter holding portion.

Embodiment 22: The filtering assembly according to embodiment 21,wherein the primary filter and the secondary filter are differentcolors.

Embodiment 23: The filtering assembly according to embodiment 21,wherein the primary filter holding portion and the secondary filterholder portion are hingedly attached.

Embodiment 24: The filtering assembly according to embodiment 21,wherein the secondary filter and the primary filter are coextensive.

Embodiment 25: The filtering assembly according to embodiment 21,wherein the secondary filter and the primary filter have differentfilter properties.

Embodiment 26: The filtering assembly according to embodiment 21,wherein the secondary filter and the primary filter have similar filterproperties.

Embodiment 27: A filter comprising: (a) a center portion of porousmaterial with a predetermined density; and (b) an edge portion of porousmaterial.

Embodiment 28: The filter according to embodiment 27, wherein the edgeportion further comprises raised silicone beads.

Embodiment 29: The filter according to embodiment 27, wherein the edgeportion is thicker than the center portion.

Embodiment 30: The filter according to embodiment 27, wherein the edgeportion comprises at least two layers of folded material.

Embodiment 31: The filter according to embodiment 27, wherein thepredetermined density of the center portion allows for passage of asterilizing agent through the center portion and prevents passage ofnongaseous agents.

Embodiment 32: A filter cartridge, the filter cartridge comprising: (a)a frame, the frame comprising a rigid or flexible edge portion anddefining a hollow center portion; and (b) a filter, the filtercomprising a porous material and being affixed to the frame, the porousmaterial being able to pass only gaseous materials through its surface,wherein the filter cartridge provides sufficient integrity to form asealed interface with a confronting surface.

Embodiment 33: The filter cartridge according to embodiment 32, thefilter cartridge further comprising a second filter, the second filtercomprising a porous material and being affixed to the frame, the porousmaterial being able to pass only gaseous materials through its surface.

Embodiment 34: The filter cartridge according to embodiment 32, thefilter cartridge further comprising a second frame, the second framecomprising a rigid or flexible edge portion and defining a hollow centerportion, the second frame being affixed to the filter.

Embodiment 35: The filter cartridge according to embodiment 34, thefilter cartridge further comprising a second filter, the second filtercomprising a porous material and being affixed to the second frame andthe filter, the porous material being able to pass only gaseousmaterials through its surface.

Embodiment 36: The filter cartridge according to embodiment 32, whereinthe filter is removeably affixed to the frame.

Embodiment 37: The filter cartridge according to embodiment 32, whereinthe frame and filter are coextensive.

Embodiment 38: The filter cartridge according to embodiment 32, whereinthe frame and the filter are integral.

The present system is distinguished from prior trays which were wrappedwith filter media, then disposed in an autoclave and transported to thesurgical field after the sterilization process, in that there is nosterilizing container having a plurality of sidewalls and an opening forreceiving an instrument tray, with a filter occluding a venting passthrough area and the ratio of venting pass through area to volume of thesterilizing container being at least 0.008 inch² per inch³ (or 1 squareinch:125 cubic inches) and in further configurations the ratio beingfrom 0.16 to 6 inch² per inch³ (or 4 square inches:25 cubic inches to 6square inches:1 cubic inch).

Further, the sterilization container of the present system canaccommodate trays with instruments or devices in the tray, wherein theinstruments or devices may or may not be wrapped with filter paper andthe tray may or may not be wrapped with filter paper. Thus, it iscontemplated the sterilization container can retain unwrapped trays withinstruments or devices, wrapped trays with instruments or devices,unwrapped instruments or devices as well as wrapped instruments ordevices wherein the ratio of the venting pass through area to volume ofthe sterilization container provides drying times less than 30 minutesand in select configurations less than 15 minutes after thesterilization cycle.

While select configurations may include a drain for passing condensatefrom the interior of the sterilization container, it is contemplatedthat other configurations having the present ratio of venting passthrough area to volume can provide the reduced drying time (such as 10minutes) without draining the condensation. In a further configuration,the floor of the sterilization container can be configured to collect orpool condensation within the container.

1-20. (canceled)
 21. A sterilization container for sterilizinginstruments in a sterilizer using a sterilizing agent, the sterilizationcontainer comprising: (a) an opening defined by a perimeter of anenclosing wall, the enclosing wall defining an interior volume sized toreceive a plurality of instrument trays; (b) a door moveable between anopen position and a closed position, wherein the interior volume isaccessible through the opening when the door is in the open position;and (c) a filter cartridge having a gasket surrounding a first filtercomprising a porous material wherein the filter cartridge is removablysecured to the door when the door is in the open position, and whereinthe gasket is positioned between the door and the enclosing wall to forma sealed interface between at least one of the door and the enclosingwall when the door is in the closed position.
 22. The sterilizationcontainer of claim 21 further comprising a filter support overlapping atleast a portion of the filter cartridge.
 23. The sterilization containerof claim 22 wherein the filter support is a vented area of the door. 24.The sterilization container of claim 22 wherein the filter support is aset of bars traversing the opening.
 25. The sterilization container ofclaim 23 wherein the door and the enclosing wall define a total surfacearea, and wherein the first filter and filter support define a ventingpass through area, wherein the venting pass through area is at least5.7% of the total surface area.
 26. The sterilization container of claim21 wherein the filter cartridge further comprises a second filter, thesecond filter comprising a porous material.
 27. The sterilizationcontainer of claim 21 wherein the gasket is a compressible seal.
 28. Thesterilization container of claim 21 wherein the door further comprisestabs or catches located along a perimeter of the door for holding thefilter cartridge adjacent the door.
 29. The sterilization container ofclaim 21 wherein the filter cartridge is single-use and disposable. 30.The sterilization container of claim 21 wherein the door includes afenestrated grid.
 31. A sterilization container for sterilizinginstruments in a sterilizer using a sterilizing agent, the sterilizationcontainer comprising: (a) an enclosing wall and a door defining a totalsurface area and an interior volume sized to receive a plurality ofinstrument trays, at least one of the enclosing wall and the doordefining a venting pass through area, wherein the door is moveablebetween an open position and a closed position, and wherein the interiorvolume is accessible when the door is in the open position; and (b) afilter cartridge having a gasket surrounding a first filter, wherein thefilter cartridge provides sufficient structural integrity to form asealing interface with at least one of a confronting surface of theenclosing wall and the door, wherein the first filter occludes theventing pass through area, and wherein the venting pass through area isat least 5.7% of the total surface area.
 32. The sterilization containerof claim 31 wherein the filter cartridge forms a sealing interface withboth the confronting surface of the enclosing wall and the door.
 33. Thesterilization container of claim 31 wherein the gasket is affixed to thefirst filter to be one of a coextensive, permanently affixed, orintegral gasket.
 34. The sterilization container of claim 31 wherein thefilter cartridge is single-use and disposable.
 35. The sterilizationcontainer of claim 31 wherein the venting pass through area is betweenapproximately 5.7% and 20% of the total surface area.
 36. Thesterilization container of claim 31 wherein the door comprises tabs orcatches located along a perimeter of the door for holding the filtercartridge adjacent the door.
 37. The sterilization container of claim31, wherein the filter cartridge further comprises a second filter, thesecond filter being affixed to the gasket opposite the first filter. 38.A method of sterilizing items in a sterilization container, the methodcomprising: (a) placing items to be sterilized into an interior volumeof a sterilization container having at least one door, the interiorvolume defined by an enclosing wall, the enclosing wall and doordefining a total surface area of the sterilization container; and (b)securing a filter cartridge having a gasket surrounding a first filterto the door, wherein the filter cartridge is sized to position thegasket between confronting surfaces of the door and the enclosing wallto engage at least one of the door and the enclosing wall when the dooris in a closed position.
 39. The method of sterilizing items in asterilization container of claim 38 further comprising the steps of: (c)securing the door in the closed position to compress the gasket and forma sealed interface between at least one of the door and the enclosingwall; and (d) sterilizing items in the sterilization container in asterilizer wherein the sterilization container is vented through aventing pass through area having the first filter occluding the ventingpass through area, wherein the venting pass through area is at least5.7% of the total surface area.
 40. The method of sterilizing items in asterilization container of claim 39 further comprising the step of: (e)drying the items in the sterilization container in less than 30 minutes.41. The method of sterilizing items in a sterilization container ofclaim 40 further comprising the steps of: (f) moving the door into anopen position, wherein the filter cartridge remains secured to the door;(g) releasing the filter cartridge from the door; and (h) disposing ofthe filter cartridge.